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Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02407990
Recruitment Status : Completed
First Posted : April 3, 2015
Results First Posted : November 17, 2021
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Cancer
Intervention Biological: BGB-A317
Enrollment 451
Recruitment Details This study was conducted in 27 centers in 5 countries, enrolled from June 2015 to October 2017 across both Phases, and was initiated in June 2015. After a 5-year period the sponsor decided to close the study as primary and secondary endpoints were met. Participants still on treatment were rolled into a separate long-term extension study (BGB-A317-290-LTE1) to continue treatment.
Pre-assignment Details  
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg BGB-A317 Phase 1B
Hide Arm/Group Description Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants were dosed at 5 mg/kg tislelizumab, Q3W until confirmed disease progression, intolerable toxicity, subject discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Period Title: Overall Study
Started 3 26 26 7 21 20 13 335
Completed 0 0 0 0 0 0 0 0
Not Completed 3 26 26 7 21 20 13 335
Reason Not Completed
Death             2             22             23             7             17             16             10             248
Lost to Follow-up             0             1             0             0             0             0             0             17
Progressive Disease             0             0             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             1             0             0             30
Study Terminated by Sponsor             1             3             3             0             3             4             3             37
Logistics             0             0             0             0             0             0             0             1
Rolled into long-term extension study             0             0             0             0             0             0             0             1
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg BGB-A317 Phase 1B Total
Hide Arm/Group Description Participants were dosed at 0.5 milligrams/kilograms (mg/kg), once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 28 days in duration. Participants were dosed at 2.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration Participants were dosed at 5.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 28 days in duration Participants were dosed at 10.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. Participants received selected dosing based on Part 1 of 2.0 mg/kg once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants received selected dosing based on Part 1 of 5.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants received selected maximum tolerated dose of 200.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, subject discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. Total of all reporting groups
Overall Number of Baseline Participants 3 26 26 7 21 20 13 335 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 26 participants 26 participants 7 participants 21 participants 20 participants 13 participants 335 participants 451 participants
54.7  (7.02) 59.1  (11.15) 57.8  (13.32) 57.1  (8.13) 63.6  (10.09) 62.6  (11.14) 58.4  (17.76) 59.5  (11.92) 59.6  (11.96)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 26 participants 26 participants 7 participants 21 participants 20 participants 13 participants 335 participants 451 participants
< 65 Years
3
 100.0%
18
  69.2%
16
  61.5%
6
  85.7%
8
  38.1%
11
  55.0%
6
  46.2%
217
  64.8%
285
  63.2%
≥ 65 Years
0
   0.0%
8
  30.8%
10
  38.5%
1
  14.3%
13
  61.9%
9
  45.0%
7
  53.8%
118
  35.2%
166
  36.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 26 participants 26 participants 7 participants 21 participants 20 participants 13 participants 335 participants 451 participants
Female
3
 100.0%
12
  46.2%
15
  57.7%
4
  57.1%
10
  47.6%
12
  60.0%
5
  38.5%
144
  43.0%
205
  45.5%
Male
0
   0.0%
14
  53.8%
11
  42.3%
3
  42.9%
11
  52.4%
8
  40.0%
8
  61.5%
191
  57.0%
246
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 26 participants 26 participants 7 participants 21 participants 20 participants 13 participants 335 participants 451 participants
Hispanic or Latino
0
   0.0%
2
   7.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8
   2.4%
10
   2.2%
Not Hispanic or Latino
3
 100.0%
24
  92.3%
26
 100.0%
7
 100.0%
21
 100.0%
20
 100.0%
13
 100.0%
322
  96.1%
436
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   1.5%
5
   1.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 26 participants 26 participants 7 participants 21 participants 20 participants 13 participants 335 participants 451 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.2%
Asian
0
   0.0%
2
   7.7%
3
  11.5%
0
   0.0%
1
   4.8%
3
  15.0%
1
   7.7%
120
  35.8%
130
  28.8%
Chinese (enrolled from Taiwan sites)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
61
  18.2%
61
  13.5%
Non-Chinese
0
   0.0%
2
   7.7%
3
  11.5%
0
   0.0%
1
   4.8%
3
  15.0%
1
   7.7%
59
  17.6%
69
  15.3%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   1.5%
5
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.6%
2
   0.4%
White
3
 100.0%
22
  84.6%
23
  88.5%
7
 100.0%
19
  90.5%
16
  80.0%
11
  84.6%
189
  56.4%
290
  64.3%
Other
0
   0.0%
2
   7.7%
0
   0.0%
0
   0.0%
1
   4.8%
1
   5.0%
1
   7.7%
18
   5.4%
23
   5.1%
1.Primary Outcome
Title Phase 1A: Number of Participants Experiencing Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected maximum tolerated dose (MTD), which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
114
  98.3%
2.Primary Outcome
Title Phase 1A: Number Of Participants With Abnormal Physical Examination Values
Hide Description A complete physical examination, vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1A. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required.
Time Frame Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
At least one postbaseline pulse rate measure ≤ 45 beats per minute (bpm)
1
   0.9%
At least one postbaseline pulse rate measure ≥ 120 bpm
6
   5.2%
At least one postbaseline SBP measure ≤ 60 millimeters of mercury (mmHg)
0
   0.0%
At least one postbaseline SBP measure ≤ 90 mmHg
9
   7.8%
At least one postbaseline SBP measure ≥ 160 mmHg
17
  14.7%
At least one postbaseline DBP measure ≥ 100 mmHg
5
   4.3%
3.Primary Outcome
Title Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings
Hide Description Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1A. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment.
Time Frame Day 15 of cycle 1, Day 1 of Cycle 2 and all additional cycles, and 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Phase 1A: Number Of Participants With Abnormal Electrocardiograms
Hide Description Electrocardiograms were obtained at pre-specified time points. Significant QT interval corrected for heart rate (QTc) prolongation was defined as an interval ≥ 500 milliseconds (msec) or an interval which increases by ≥ 60 msec over baseline.
Time Frame Days 1 and 15 of cycle 1; Day 1 of cycle 2 and all additional cycles; Day 1 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 postbaseline QT corrected using Fridericia's formula (QTcF) Interval measure of >450 msec
31
  26.7%
At least 1 postbaseline QTcF Interval measure of > 480 msec
9
   7.8%
At least 1 postbaseline QTcF Interval measure of > 500 msec
3
   2.6%
At least 1 postbaseline QTcF Interval measure ≤ 30 msec increase from baseline
73
  62.9%
At least 1 postbaseline QTcF Interval measure ≤ 30 and ≤ 60 msec increase from baseline
35
  30.2%
At least 1 postbaseline QTcF Interval measure > 60 msec increase from baseline
8
   6.9%
5.Primary Outcome
Title Phase 1A: Number Of Participants With Abnormal Laboratory Values
Hide Description Clinical chemistry, hematology, coagulation, and urinalysis were performed at pre-specified time points for Phase 1A. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to ≥ Grade 3 are reported.
Time Frame Day -28 (predose), Days 1, 8, and 15 of cycle 1; Days 1 and 15 of cycle 2 and additional cycles; Days 1 and 15 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who had received any dose of tislelizumab and with baseline assessment and at least one post-baseline assessment. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase: High
6
   5.2%
Albumin: Low
11
   9.5%
Alkaline Phosphatase: High
7
   6.0%
Aspartate Aminotransferase: High
5
   4.3%
Bilirubin: High
7
   6.0%
Calcium: Low
7
   6.0%
Calcium: High
2
   1.7%
Creatinine: High
6
   5.2%
Glucose: Low
5
   4.3%
Glucose: High
13
  11.2%
Hemoglobin: Low
6
   5.2%
Leukocytes: Low
3
   2.6%
Leukocytes: High
0
   0.0%
Lymphocytes: Low
22
  19.0%
Lymphocytes: High
2
   1.7%
Neutrophils: Low
2
   1.7%
Phosphate: Low
19
  16.4%
Platelets: Low
1
   0.9%
Potassium: Low
21
  18.1%
Potassium: High
7
   6.0%
Sodium: Low
8
   6.9%
Sodium: High
0
   0.0%
6.Primary Outcome
Title Phase 1A: Number Of Participants Experiencing Severe AEs
Hide Description All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and serious adverse event (SAE) recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
14
  12.1%
7.Primary Outcome
Title Phase 1B: Objective Response Rate (ORR)
Hide Description The ORR was defined as the percentage of participants in the study whose best overall response was either complete response (CR) or partial response (PR) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EFF) included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.6
(8.41 to 15.57)
8.Secondary Outcome
Title Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 3 6 6 6 18 20 12
Mean (Standard Deviation)
Unit of Measure: micrograms/milliliter*day
84.92  (35.90) 332.2  (57.33) 811.8  (239.5) 1916.0  (458.5) 512.1  (122.2) 1219.0  (287.4) 674.7  (173.6)
9.Secondary Outcome
Title Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 3 6 6 6 18 20 12
Mean (Standard Deviation)
Unit of Measure: micrograms/milliliter
13.5  (3.80) 48.3  (6.89) 147.0  (50.8) 278.0  (53.7) 56.8  (12.8) 130.0  (29.7) 77.2  (13.9)
10.Secondary Outcome
Title Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W). until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 3 6 6 6 18 20 12
Mean (Standard Deviation)
Unit of Measure: hours
3.46  (3.12) 2.39  (0.89) 2.48  (0.73) 2.43  (1.83) 1.57  (0.65) 4.95  (15.4) 1.40  (0.82)
11.Secondary Outcome
Title Phase 1A: Half-life (T½) For Tislelizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W). until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 3 6 6 6 18 20 12
Mean (Standard Deviation)
Unit of Measure: hours
10.7  (3.90) 12.9  (1.2) 15.0  (14.4) 14.5  (4.04) 17.1  (8.14) 19.6  (7.63) 16.8  (5.50)
12.Secondary Outcome
Title Phase 1A - Part 3: Clearance (Cl) For Tislelizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. per-pre-specification, data was analyzed only for Part 3 of Phase 1A.
Arm/Group Title BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: liters/day
0.186
(0.135 to 0.256)
13.Secondary Outcome
Title Phase 1A/1B: Number Of Participants With Anti-drug Antibodies (ADAs)
Hide Description Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs, which included positive ADAs and neutralizing antibodies (NAb).
Time Frame Day 1 of Cycles 1 through 15
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable set: participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.
Arm/Group Title BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg and BGB-A317 Phase 1B BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg
Hide Arm/Group Description:
Participants were dosed at 0.5 milligrams/kilograms (mg/kg), once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 2.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants were dosed at 5.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration
Participants were dosed at 10.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.
Participants received selected dosing based on Part 1 of 2.0 mg/kg once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.

Phase 1A: Participants received selected dosing based on Part 1 of 5.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 21 days in duration.

Phase 1B; Participants were dosed at 5 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.

Participants received selected maximum tolerated dose of 200.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 3 21 25 6 19 285 11
Measure Type: Number
Unit of Measure: Participants
1 6 5 1 6 43 3
14.Secondary Outcome
Title Phase 1A: ORR
Hide Description The ORR was defined as the percentage of participants in the study whose best overall response was either CR or PR as assessed by investigators based on RECIST v 1.1.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.1
(11.57 to 26.33)
15.Secondary Outcome
Title Phase 1A: CR Rate
Hide Description The CR rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
6
   5.2%
16.Secondary Outcome
Title Phase 1A: PR Rate
Hide Description The PR rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
15
  12.9%
17.Secondary Outcome
Title Phase 1A: Stable Disease (SD) Rate
Hide Description The SD rate was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Measure Type: Count of Participants
Unit of Measure: Participants
42
  36.2%
18.Secondary Outcome
Title Phase 1A: Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.1 to 3.8)
19.Secondary Outcome
Title Phase 1A: Overall Survival (OS)
Hide Description OS was defined as the time interval between the date of the first study drug dose to the date of death for any cause. Kaplan-Meier methodology was used to estimate OS at various time points. The OS was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Median (95% Confidence Interval)
Unit of Measure: months
13.6
(9.9 to 17.5)
20.Secondary Outcome
Title Phase 1A: Duration Of Response (DOR)
Hide Description DOR for responders (CR or PR) was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease or death for any cause, whichever occurred earlier. For participants who were alive without progression following the qualifying response, DOR was censored on the date of last evaluable tumor assessment or last follow-up for progression of disease. The DOR was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
Arm/Group Title BGB-A317 Phase 1A
Hide Arm/Group Description:
In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 116
Median (95% Confidence Interval)
Unit of Measure: months
14.6 [1] 
(8.3 to NA)
[1]
NA = Not estimable due to insufficient number of participants with events
21.Secondary Outcome
Title Phase 1B: Number of Participants Experiencing AEs
Hide Description An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the NCI-CTCAE (v 4.03 2010).
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
322
  96.1%
22.Secondary Outcome
Title Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab
Hide Description [Not Specified]
Time Frame Pre-dose, Day 1 Cycle 5 and every other Cycle in the first 6 months, every 4 cycles in the next 6 months, once every 6 months up to end of treatment (up to 5 years and 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 145
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter
Non-Small Cell Lung Cancer Number Analyzed 30 participants
63.9
(47.8%)
Ovarian Cancer Number Analyzed 10 participants
90.4
(66.7%)
Gastric Cancer Number Analyzed 15 participants
40.7
(91.4%)
Hepatocellular Carcinoma Number Analyzed 27 participants
54.4
(56.8%)
Head & Neck Squamous Cell Carcinoma Number Analyzed 11 participants
77.4
(45.8%)
Esophageal Carcinoma Number Analyzed 18 participants
57.8
(62.4%)
Triple Negative Breast Cancer Number Analyzed 3 participants
47.8
(78.9%)
Cholangio Carcinoma Number Analyzed 7 participants
65.7
(47.9%)
Other Solid Tumors Number Analyzed 24 participants
80.4
(43.5%)
23.Secondary Outcome
Title Phase 1B: PFS
Hide Description PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(2.0 to 2.2)
24.Secondary Outcome
Title Phase 1B: Disease Control Rate (DCR)
Hide Description The DCR was defined as the percentage of participants who achieve CR, PR, and SD based on RECIST v 1.1 in participants with select tumor types.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.2
(35.87 to 46.67)
25.Secondary Outcome
Title Phase 1B: Clinical Benefit Rate (CBR)
Hide Description The CBR was defined as the percentage of participants who achieved CR, PR, and durable SD [SD ≥24 weeks] based on RECIST v 1.1 in participants with select tumor types.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(19.97 to 29.45)
26.Secondary Outcome
Title Phase 1B: Number Of Participants With Abnormal Physical Examination Values
Hide Description A complete physical examination, vital signs (SBP, DBP, pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1B. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required.
Time Frame Day -28 (predose), Days 1, 4, 8, and 15 of cycle 1; Day 1 of cycle 2; through 30 (+/- 7) days after last dose up to 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: all participants who had received any dose of tislelizumab and with baseline.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
At least one postbaseline pulse rate measure ≤ 45 bpm Number Analyzed 312 participants
5
   1.6%
At least one postbaseline pulse rate measure ≥ 120 bpm Number Analyzed 312 participants
26
   8.3%
At least one postbaseline SBP measure ≤ 60 mmHg Number Analyzed 312 participants
1
   0.3%
At least one postbaseline SBP measure ≤ 90 mmHg Number Analyzed 312 participants
24
   7.7%
At least one postbaseline SBP measure ≥ 160 mmHg Number Analyzed 312 participants
30
   9.6%
At least one postbaseline DBP measure ≥ 100 mmHg Number Analyzed 312 participants
12
   3.8%
27.Secondary Outcome
Title Phase 1B: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings
Hide Description Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1B. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment.
Time Frame Day -28 (predose), Day 1 of cycle 2 and additional cycles, and 30 (+/- 7) days after last dose up to 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
28.Secondary Outcome
Title Phase 1B: Number Of Participants With Abnormal Electrocardiograms
Hide Description Electrocardiograms were obtained at pre-specified time points. Significant QTc prolongation was defined as an interval ≥ 500 msec or an interval which increases by ≥ 60 msec over baseline.
Time Frame Day -28 (predose), Days 1 and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: all participants who had received any dose of tislelizumab.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 postbaseline QTcF Interval measure > 450 msec Number Analyzed 312 participants
84
  26.9%
At least 1 postbaseline QTcF Interval measure > 480 msec Number Analyzed 312 participants
24
   7.7%
At least 1 postbaseline QTcF Interval measure > 500 msec Number Analyzed 312 participants
10
   3.2%
At least 1 postbaseline QTcF Interval measure ≤ 30 msec increase from baseline Number Analyzed 312 participants
241
  77.2%
At least 1 postbaseline QTcF Interval measure >30 and ≤ 60 msec increase from baseline Number Analyzed 312 participants
67
  21.5%
At least 1 postbaseline QTcF Interval measure > 60 msec increase Number Analyzed 312 participants
22
   7.1%
29.Secondary Outcome
Title Phase 1B: Number Of Participants With Abnormal Laboratory Values
Hide Description Clinical chemistry, hematology, coagulation, and urinalysis will be performed at pre-specified time points for Phase 1A and Phase 1B respectively. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to ≥ Grade 3 are reported.
Time Frame Day -28 (predose), Days 1, 8, and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who had received any dose of tislelizumab.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase: High Number Analyzed 335 participants
21
   6.3%
Albumin: Low Number Analyzed 335 participants
42
  12.5%
Alkaline Phosphatase: High Number Analyzed 335 participants
21
   6.3%
Aspartate Aminotransferase: High Number Analyzed 335 participants
21
   6.3%
Bilirubin: High Number Analyzed 335 participants
22
   6.6%
Calcium: Low Number Analyzed 335 participants
12
   3.6%
Calcium: High Number Analyzed 335 participants
7
   2.1%
Creatinine: High Number Analyzed 335 participants
20
   6.0%
Glucose: Low Number Analyzed 335 participants
8
   2.4%
Glucose: High Number Analyzed 335 participants
32
   9.6%
Hemoglobin: Low Number Analyzed 335 participants
19
   5.7%
Leukocytes: Low Number Analyzed 335 participants
8
   2.4%
Leukocytes: High Number Analyzed 335 participants
1
   0.3%
Lymphocytes: Low Number Analyzed 223 participants
33
  14.8%
Lymphocytes: High Number Analyzed 223 participants
2
   0.9%
Neutrophils: Low Number Analyzed 223 participants
5
   2.2%
Phosphate: Low Number Analyzed 335 participants
42
  12.5%
Platelets: Low Number Analyzed 335 participants
3
   0.9%
Potassium: Low Number Analyzed 335 participants
35
  10.4%
Potassium: High Number Analyzed 335 participants
4
   1.2%
Sodium: Low Number Analyzed 335 participants
25
   7.5%
Sodium: High Number Analyzed 335 participants
1
   0.3%
30.Secondary Outcome
Title Phase 1B: Number Of Participants Experiencing Severe AEs
Hide Description All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and SAE recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe.
Time Frame Day -28 through 5 years and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab.
Arm/Group Title BGB-A317 Phase 1B
Hide Arm/Group Description:
Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
27
   8.1%
Time Frame Day -28 through 5 years and 2 months
Adverse Event Reporting Description The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.
 
Arm/Group Title BGB-A317 Phase 1A BGB-A317 Phase 1B
Hide Arm/Group Description In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which is 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 21 days in duration. Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration.
All-Cause Mortality
BGB-A317 Phase 1A BGB-A317 Phase 1B
Affected / at Risk (%) Affected / at Risk (%)
Total   97/116 (83.62%)   249/335 (74.33%) 
Hide Serious Adverse Events
BGB-A317 Phase 1A BGB-A317 Phase 1B
Affected / at Risk (%) Affected / at Risk (%)
Total   40/116 (34.48%)   131/335 (39.10%) 
Blood and lymphatic system disorders     
Anaemia  1  1/116 (0.86%)  1/335 (0.30%) 
Lymphadenopathy  1  0/116 (0.00%)  2/335 (0.60%) 
Iron deficiency anaemia  1  0/116 (0.00%)  1/335 (0.30%) 
Cardiac disorders     
Atrial fibrillation  1  0/116 (0.00%)  2/335 (0.60%) 
Arteriosclerosis coronary artery  1  0/116 (0.00%)  1/335 (0.30%) 
Myocardial ischaemia  1  0/116 (0.00%)  1/335 (0.30%) 
Gastrointestinal disorders     
Vomiting  1  2/116 (1.72%)  6/335 (1.79%) 
Abdominal pain  1  3/116 (2.59%)  3/335 (0.90%) 
Ascites  1  2/116 (1.72%)  4/335 (1.19%) 
Colitis  1  3/116 (2.59%)  2/335 (0.60%) 
Dysphagia  1  0/116 (0.00%)  5/335 (1.49%) 
Nausea  1  2/116 (1.72%)  3/335 (0.90%) 
Diarrhoea  1  2/116 (1.72%)  2/335 (0.60%) 
Upper gastrointestinal haemorrhage  1  1/116 (0.86%)  3/335 (0.90%) 
Constipation  1  0/116 (0.00%)  3/335 (0.90%) 
Small intestinal obstruction  1  1/116 (0.86%)  2/335 (0.60%) 
Abdominal distension  1  0/116 (0.00%)  2/335 (0.60%) 
Abdominal pain upper  1  1/116 (0.86%)  1/335 (0.30%) 
Gastrointestinal haemorrhage  1  0/116 (0.00%)  2/335 (0.60%) 
Intestinal obstruction  1  0/116 (0.00%)  2/335 (0.60%) 
Oesophageal obstruction  1  0/116 (0.00%)  2/335 (0.60%) 
Autoimmune colitis  1  1/116 (0.86%)  0/335 (0.00%) 
Autoimmune pancreatitis  1  1/116 (0.86%)  0/335 (0.00%) 
Duodenal ulcer  1  1/116 (0.86%)  0/335 (0.00%) 
Dyspepsia  1  0/116 (0.00%)  1/335 (0.30%) 
Faecaloma  1  0/116 (0.00%)  1/335 (0.30%) 
Frequent bowel movements  1  0/116 (0.00%)  1/335 (0.30%) 
Gastric ulcer  1  0/116 (0.00%)  1/335 (0.30%) 
Gastric ulcer perforation  1  0/116 (0.00%)  1/335 (0.30%) 
Gastric varices  1  0/116 (0.00%)  1/335 (0.30%) 
Gastritis  1  1/116 (0.86%)  0/335 (0.00%) 
Gastrointestinal obstruction  1  0/116 (0.00%)  1/335 (0.30%) 
Gingival bleeding  1  0/116 (0.00%)  1/335 (0.30%) 
Ileus  1  0/116 (0.00%)  1/335 (0.30%) 
Lower gastrointestinal haemorrhage  1  0/116 (0.00%)  1/335 (0.30%) 
Obstruction gastric  1  0/116 (0.00%)  1/335 (0.30%) 
Oesophageal haemorrhage  1  0/116 (0.00%)  1/335 (0.30%) 
Oesophageal varices haemorrhage  1  0/116 (0.00%)  1/335 (0.30%) 
Small intestinal haemorrhage  1  0/116 (0.00%)  1/335 (0.30%) 
Stomatitis  1  0/116 (0.00%)  1/335 (0.30%) 
General disorders     
Pyrexia  1  2/116 (1.72%)  6/335 (1.79%) 
Asthenia  1  0/116 (0.00%)  1/335 (0.30%) 
Fatigue  1  0/116 (0.00%)  1/335 (0.30%) 
Multiple organ dysfunction syndrome  1  1/116 (0.86%)  0/335 (0.00%) 
Oedema peripheral  1  1/116 (0.86%)  0/335 (0.00%) 
Peripheral swelling  1  1/116 (0.86%)  0/335 (0.00%) 
Hepatobiliary disorders     
Hepatitis  1  0/116 (0.00%)  3/335 (0.90%) 
Cholangitis  1  0/116 (0.00%)  2/335 (0.60%) 
Bile duct obstruction  1  0/116 (0.00%)  1/335 (0.30%) 
Cholangitis acute  1  0/116 (0.00%)  1/335 (0.30%) 
Hepatic failure  1  0/116 (0.00%)  1/335 (0.30%) 
Hepatitis acute  1  0/116 (0.00%)  1/335 (0.30%) 
Jaundice cholestatic  1  0/116 (0.00%)  1/335 (0.30%) 
Immune system disorders     
Contrast media allergy  1  0/116 (0.00%)  1/335 (0.30%) 
Infections and infestations     
Pneumonia  1  4/116 (3.45%)  16/335 (4.78%) 
Lower respiratory tract infection  1  0/116 (0.00%)  4/335 (1.19%) 
Sepsis  1  0/116 (0.00%)  4/335 (1.19%) 
Infective exacerbation of chronic obstructive airways disease  1  0/116 (0.00%)  2/335 (0.60%) 
Septic shock  1  0/116 (0.00%)  2/335 (0.60%) 
Acute sinusitis  1  1/116 (0.86%)  0/335 (0.00%) 
Bacterascites  1  0/116 (0.00%)  1/335 (0.30%) 
Biliary tract infection  1  0/116 (0.00%)  1/335 (0.30%) 
Bone tuberculosis  1  0/116 (0.00%)  1/335 (0.30%) 
Breast cellulitis  1  0/116 (0.00%)  1/335 (0.30%) 
Bronchitis  1  0/116 (0.00%)  1/335 (0.30%) 
Campylobacter gastroenteritis  1  1/116 (0.86%)  0/335 (0.00%) 
Cellulitis  1  0/116 (0.00%)  1/335 (0.30%) 
Complicated appendicitis  1  0/116 (0.00%)  1/335 (0.30%) 
Diverticulitis  1  0/116 (0.00%)  1/335 (0.30%) 
Gastroenteritis salmonella  1  0/116 (0.00%)  1/335 (0.30%) 
Infection  1  0/116 (0.00%)  1/335 (0.30%) 
Mediastinitis  1  0/116 (0.00%)  1/335 (0.30%) 
Orbital infection  1  0/116 (0.00%)  1/335 (0.30%) 
Osteomyelitis  1  0/116 (0.00%)  1/335 (0.30%) 
Parotitis  1  0/116 (0.00%)  1/335 (0.30%) 
Peritonitis  1  0/116 (0.00%)  1/335 (0.30%) 
Pneumonia bacterial  1  0/116 (0.00%)  1/335 (0.30%) 
Respiratory syncytial virus infection  1  0/116 (0.00%)  1/335 (0.30%) 
Sinusitis  1  0/116 (0.00%)  1/335 (0.30%) 
Soft tissue infection  1  0/116 (0.00%)  1/335 (0.30%) 
Tooth infection  1  1/116 (0.86%)  0/335 (0.00%) 
Upper respiratory tract infection  1  0/116 (0.00%)  1/335 (0.30%) 
Urinary tract infection  1  0/116 (0.00%)  1/335 (0.30%) 
Vascular device infection  1  1/116 (0.86%)  0/335 (0.00%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/116 (0.86%)  1/335 (0.30%) 
Procedural pain  1  0/116 (0.00%)  2/335 (0.60%) 
Fall  1  0/116 (0.00%)  1/335 (0.30%) 
Hand fracture  1  1/116 (0.86%)  0/335 (0.00%) 
Procedural hypotension  1  0/116 (0.00%)  1/335 (0.30%) 
Toxicity to various agents  1  0/116 (0.00%)  1/335 (0.30%) 
Investigations     
Aspartate aminotransferase increased  1  0/116 (0.00%)  2/335 (0.60%) 
Alanine aminotransferase increased  1  0/116 (0.00%)  1/335 (0.30%) 
Blood creatinine increased  1  1/116 (0.86%)  0/335 (0.00%) 
Ejection fraction decreased  1  1/116 (0.86%)  0/335 (0.00%) 
Metabolism and nutrition disorders     
Cachexia  1  0/116 (0.00%)  2/335 (0.60%) 
Diabetic ketoacidosis  1  2/116 (1.72%)  0/335 (0.00%) 
Hyperglycaemia  1  2/116 (1.72%)  0/335 (0.00%) 
Hypokalaemia  1  1/116 (0.86%)  1/335 (0.30%) 
Type 1 diabetes mellitus  1  2/116 (1.72%)  0/335 (0.00%) 
Decreased appetite  1  0/116 (0.00%)  1/335 (0.30%) 
Dehydration  1  1/116 (0.86%)  0/335 (0.00%) 
Hyperkalaemia  1  0/116 (0.00%)  1/335 (0.30%) 
Hypomagnesaemia  1  1/116 (0.86%)  0/335 (0.00%) 
Latent autoimmune diabetes in adults  1  1/116 (0.86%)  0/335 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/116 (1.72%)  4/335 (1.19%) 
Arthralgia  1  0/116 (0.00%)  1/335 (0.30%) 
Arthritis  1  0/116 (0.00%)  1/335 (0.30%) 
Musculoskeletal chest pain  1  1/116 (0.86%)  0/335 (0.00%) 
Pathological fracture  1  0/116 (0.00%)  1/335 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant ascites  1  0/116 (0.00%)  2/335 (0.60%) 
Squamous cell carcinoma of skin  1  1/116 (0.86%)  1/335 (0.30%) 
Adenocarcinoma of colon  1  0/116 (0.00%)  1/335 (0.30%) 
Basal cell carcinoma  1  1/116 (0.86%)  0/335 (0.00%) 
Lip squamous cell carcinoma  1  0/116 (0.00%)  1/335 (0.30%) 
Malignant neoplasm progression  1  0/116 (0.00%)  1/335 (0.30%) 
Tumour haemorrhage  1  0/116 (0.00%)  1/335 (0.30%) 
Nervous system disorders     
Basal ganglia infarction  1  1/116 (0.86%)  0/335 (0.00%) 
Brain oedema  1  0/116 (0.00%)  1/335 (0.30%) 
Dysaesthesia  1  0/116 (0.00%)  1/335 (0.30%) 
Headache  1  0/116 (0.00%)  1/335 (0.30%) 
IIIrd nerve paralysis  1  0/116 (0.00%)  1/335 (0.30%) 
Lethargy  1  0/116 (0.00%)  1/335 (0.30%) 
Sciatica  1  0/116 (0.00%)  1/335 (0.30%) 
Spinal cord compression  1  0/116 (0.00%)  1/335 (0.30%) 
Thoracic radiculopathy  1  1/116 (0.86%)  0/335 (0.00%) 
Product Issues     
Device occlusion  1  0/116 (0.00%)  1/335 (0.30%) 
Psychiatric disorders     
Delirium  1  0/116 (0.00%)  1/335 (0.30%) 
Renal and urinary disorders     
Acute kidney injury  1  0/116 (0.00%)  1/335 (0.30%) 
Haematuria  1  0/116 (0.00%)  1/335 (0.30%) 
Urinary retention  1  0/116 (0.00%)  1/335 (0.30%) 
Urinary tract obstruction  1  1/116 (0.86%)  0/335 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/116 (0.86%)  8/335 (2.39%) 
Pleural effusion  1  1/116 (0.86%)  5/335 (1.49%) 
Pulmonary embolism  1  3/116 (2.59%)  1/335 (0.30%) 
Dyspnoea  1  1/116 (0.86%)  0/335 (0.00%) 
Epistaxis  1  0/116 (0.00%)  1/335 (0.30%) 
Haemoptysis  1  0/116 (0.00%)  1/335 (0.30%) 
Immune-mediated pneumonitis  1  0/116 (0.00%)  1/335 (0.30%) 
Pleuritic pain  1  0/116 (0.00%)  1/335 (0.30%) 
Pneumonia aspiration  1  0/116 (0.00%)  1/335 (0.30%) 
Pneumothorax  1  1/116 (0.86%)  0/335 (0.00%) 
Respiratory failure  1  0/116 (0.00%)  1/335 (0.30%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/116 (0.00%)  1/335 (0.30%) 
Vascular disorders     
Deep vein thrombosis  1  0/116 (0.00%)  1/335 (0.30%) 
Haematoma  1  1/116 (0.86%)  0/335 (0.00%) 
Hypotension  1  1/116 (0.86%)  0/335 (0.00%) 
Jugular vein thrombosis  1  0/116 (0.00%)  1/335 (0.30%) 
Lymphoedema  1  0/116 (0.00%)  1/335 (0.30%) 
Venous occlusion  1  1/116 (0.86%)  0/335 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
BGB-A317 Phase 1A BGB-A317 Phase 1B
Affected / at Risk (%) Affected / at Risk (%)
Total   112/116 (96.55%)   302/335 (90.15%) 
Blood and lymphatic system disorders     
Anaemia  1  12/116 (10.34%)  28/335 (8.36%) 
Endocrine disorders     
Hypothyroidism  1  8/116 (6.90%)  22/335 (6.57%) 
Hyperthyroidism  1  5/116 (4.31%)  14/335 (4.18%) 
Eye disorders     
Dry eye  1  7/116 (6.03%)  7/335 (2.09%) 
Gastrointestinal disorders     
Nausea  1  41/116 (35.34%)  71/335 (21.19%) 
Diarrhoea  1  33/116 (28.45%)  49/335 (14.63%) 
Constipation  1  28/116 (24.14%)  51/335 (15.22%) 
Abdominal pain  1  25/116 (21.55%)  42/335 (12.54%) 
Vomiting  1  19/116 (16.38%)  42/335 (12.54%) 
Abdominal pain upper  1  9/116 (7.76%)  19/335 (5.67%) 
Abdominal distension  1  6/116 (5.17%)  17/335 (5.07%) 
Gastrooesophageal reflux disease  1  6/116 (5.17%)  17/335 (5.07%) 
Dry mouth  1  6/116 (5.17%)  11/335 (3.28%) 
Dysphagia  1  3/116 (2.59%)  11/335 (3.28%) 
Ascites  1  5/116 (4.31%)  4/335 (1.19%) 
Dyspepsia  1  4/116 (3.45%)  4/335 (1.19%) 
Mouth ulceration  1  4/116 (3.45%)  3/335 (0.90%) 
General disorders     
Fatigue  1  47/116 (40.52%)  80/335 (23.88%) 
Pyrexia  1  7/116 (6.03%)  31/335 (9.25%) 
Oedema peripheral  1  13/116 (11.21%)  24/335 (7.16%) 
Non-cardiac chest pain  1  9/116 (7.76%)  12/335 (3.58%) 
Influenza like illness  1  4/116 (3.45%)  6/335 (1.79%) 
Infections and infestations     
Upper respiratory tract infection  1  15/116 (12.93%)  28/335 (8.36%) 
Urinary tract infection  1  8/116 (6.90%)  22/335 (6.57%) 
Oral candidiasis  1  8/116 (6.90%)  17/335 (5.07%) 
Lower respiratory tract infection  1  4/116 (3.45%)  11/335 (3.28%) 
Pneumonia  1  4/116 (3.45%)  9/335 (2.69%) 
Nasopharyngitis  1  4/116 (3.45%)  7/335 (2.09%) 
Oral herpes  1  4/116 (3.45%)  2/335 (0.60%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  12/116 (10.34%)  13/335 (3.88%) 
Investigations     
Weight decreased  1  5/116 (4.31%)  35/335 (10.45%) 
Alanine aminotransferase increased  1  9/116 (7.76%)  17/335 (5.07%) 
Aspartate aminotransferase increased  1  4/116 (3.45%)  18/335 (5.37%) 
Blood creatinine increased  1  7/116 (6.03%)  12/335 (3.58%) 
Metabolism and nutrition disorders     
Decreased appetite  1  20/116 (17.24%)  74/335 (22.09%) 
Hypokalaemia  1  5/116 (4.31%)  17/335 (5.07%) 
Hypercalcaemia  1  6/116 (5.17%)  15/335 (4.48%) 
Hypomagnesaemia  1  5/116 (4.31%)  8/335 (2.39%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  26/116 (22.41%)  40/335 (11.94%) 
Arthralgia  1  10/116 (8.62%)  23/335 (6.87%) 
Musculoskeletal pain  1  8/116 (6.90%)  21/335 (6.27%) 
Musculoskeletal chest pain  1  11/116 (9.48%)  11/335 (3.28%) 
Pain in extremity  1  10/116 (8.62%)  12/335 (3.58%) 
Muscle spasms  1  7/116 (6.03%)  7/335 (2.09%) 
Myalgia  1  7/116 (6.03%)  7/335 (2.09%) 
Nervous system disorders     
Headache  1  9/116 (7.76%)  28/335 (8.36%) 
Dizziness  1  10/116 (8.62%)  12/335 (3.58%) 
Lethargy  1  5/116 (4.31%)  2/335 (0.60%) 
Psychiatric disorders     
Insomnia  1  5/116 (4.31%)  29/335 (8.66%) 
Anxiety  1  8/116 (6.90%)  6/335 (1.79%) 
Renal and urinary disorders     
Proteinuria  1  3/116 (2.59%)  14/335 (4.18%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/116 (14.66%)  46/335 (13.73%) 
Dyspnoea  1  11/116 (9.48%)  35/335 (10.45%) 
Oropharyngeal pain  1  2/116 (1.72%)  12/335 (3.58%) 
Productive cough  1  5/116 (4.31%)  9/335 (2.69%) 
Dyspnoea exertional  1  6/116 (5.17%)  7/335 (2.09%) 
Wheezing  1  4/116 (3.45%)  8/335 (2.39%) 
Skin and subcutaneous tissue disorders     
Rash  1  23/116 (19.83%)  39/335 (11.64%) 
Pruritus  1  21/116 (18.10%)  38/335 (11.34%) 
Rash maculo-papular  1  9/116 (7.76%)  12/335 (3.58%) 
Dry skin  1  2/116 (1.72%)  12/335 (3.58%) 
Rash erythematous  1  4/116 (3.45%)  6/335 (1.79%) 
Night sweats  1  7/116 (6.03%)  1/335 (0.30%) 
Hyperhidrosis  1  4/116 (3.45%)  2/335 (0.60%) 
Vascular disorders     
Hot flush  1  4/116 (3.45%)  6/335 (1.79%) 
Hypotension  1  5/116 (4.31%)  5/335 (1.49%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: BeiGene
Phone: +1-877-828-5568
EMail: clinicaltrials@beigene.com
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02407990    
Other Study ID Numbers: BGB-A317_Study_001
First Submitted: March 26, 2015
First Posted: April 3, 2015
Results First Submitted: August 6, 2021
Results First Posted: November 17, 2021
Last Update Posted: November 17, 2021