ClinicalTrials.gov

History of Changes for Study: NCT02407990
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors
Latest version (submitted October 18, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 31, 2015 None (earliest Version on record)
2 May 6, 2015 Study Status and Oversight
3 June 9, 2015 Recruitment Status, Study Status and Contacts/Locations
4 August 11, 2015 Study Status and Contacts/Locations
5 August 28, 2015 Contacts/Locations and Study Status
6 September 15, 2015 Study Status, Eligibility and Study Identification
7 January 5, 2016 Study Status, Contacts/Locations and Oversight
8 January 13, 2016 Contacts/Locations, Study Design and Study Status
9 February 4, 2016 Contacts/Locations and Study Status
10 June 23, 2016 Contacts/Locations and Study Status
11 February 21, 2017 Study Status, Contacts/Locations and Study Design
12 December 12, 2017 Recruitment Status, Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Design and Eligibility
13 July 13, 2018 Study Status and Contacts/Locations
14 July 16, 2018 Contacts/Locations and Study Status
15 July 31, 2019 Study Status
16 September 9, 2019 Study Status
17 October 23, 2019 Contacts/Locations and Study Status
18 October 30, 2019 Study Status
19 November 1, 2019 Study Status
20 January 13, 2020 Study Status, IPDSharing, Eligibility, Outcome Measures, Arms and Interventions, Study Description and Study Identification
21 March 23, 2020 IPDSharing and Study Status
22 July 9, 2020 Study Status, References and Arms and Interventions
23 November 6, 2020 Study Status
24 March 31, 2021 Recruitment Status, Study Status
Show
Results Submission Events
25 October 18, 2021 Outcome Measures, Study Status, Contacts/Locations, Oversight, Document Section, Results, IPDSharing, Eligibility, Arms and Interventions and Study Description
Comparison Format:

Scroll up to access the controls

Study NCT02407990
Submitted Date:  March 31, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGB-A317_Study_001
Brief Title: Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors
Official Title: A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: June 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: December 2017 [Anticipated]
First Submitted: March 26, 2015
First Submitted that
Met QC Criteria:
March 31, 2015
First Posted: April 3, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 31, 2015
Last Update Posted: April 3, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: BeiGene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in patients with advanced tumors.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 64 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BGB-A317 Biological: BGB-A317

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events
[ Time Frame: From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month ]

Secondary Outcome Measures:
1. Area under the plasma concentration-time curve (AUC)
[ Time Frame: During first 4 months ]

2. Maximum plasma concentration (Cmax)
[ Time Frame: During first 4 months ]

3. Time to reach maximum plasma concentration (Tmax)
[ Time Frame: During first 4 months ]

4. Terminal elimination half-life (t1/2)
[ Time Frame: During first 4 months ]

5. Disease assessment by CT/MRI scan
[ Time Frame: Performed at an expected average of 10 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]

6. Anti-BGB-A317 antibody
[ Time Frame: Performed at an expected average of 6 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Subjects must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available.
  2. Subjects with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids and anti seizure medications for 4 weeks prior to enrollment are permitted.
  3. Subjects must have archival tumor tissues or agree to a tumor biopsy for analysis of predictive biomarkers such as PD-L1. (Fresh tumor biopsies are strongly recommended at baseline for biomarker analysis in subjects with readily accessible tumor lesions and who consent to the biopsies.)
  4. Subjects must have measurable disease as defined per RECIST Version 1.1.
  5. Male or female and ≥18 years of age on day of signing informed consent.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  7. Subjects must have adequate organ function as indicated by the following laboratory values.
    • Absolute neutrophil count (ANC) ≥1,500 /mL
    • Platelets ≥100,000 / mL
    • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications
    • Serum creatinine ≤1.5 X upper limit of normal (ULN)
    • Serum total bilirubin ≤ 1.5 X ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN
    • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
  8. Subjects have voluntarily agreed to participate by giving written informed consent.
  9. Female subjects are eligible to enter and participate in the study if they
    • Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who
      • Has had a hysterectomy.
      • Has had a bilateral oophorectomy (ovariectomy).
      • Has had a bilateral tubal ligation.
      • Is post menopausal (total cessation of menses for ≥1 year).
    • Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 90 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
      • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
      • Any intrauterine device with a documented failure rate of less than 1% per year.
      • Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
      • Not be breast feeding.
  10. Male subjects are eligible to enter and participate in the study if they are vasectomized or agree to the use of contraception during the study treatment period and for at least 180 days after the last dose of study drug

Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other mAbs.
  2. Prior malignancy active within the previous 2 years except for tumor for which a patient is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
  3. Prior therapies targeting PD-1 or PD-L1.
  4. Subjects who fail to meet enrollment criteria for other PD-1 or PD-L1 trials solely due to low or negative predictive biomarkers.
  5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
  6. Subjects should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
  7. Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies..
  8. Known history of Human Immunodeficiency Virus;
  9. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA);
  10. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
  11. Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter) before study drug administration, and all adverse events have either returned to baseline or stabilized.
  12. Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.
Open or close this module Contacts/Locations
Central Contact Person: Jason Yang, MD, PhD
Telephone: +86 10 5895 8018
Email: jason.yang@beigene.com
Study Officials: Jason Yang, MD, PhD
Study Director
BeiGene
Locations: Australia, Victoria
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin Health Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research/Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services