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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02407990
First Posted: April 3, 2015
Last Update Posted: December 13, 2017
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.
Information provided by (Responsible Party):
BeiGene
  Purpose
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.

Condition Intervention Phase
Advanced Cancer Biological: BGB-A317 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1A/1B, 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

Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Phase 1A: 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 ]
  • Phase 1B: Overall response based on RECIST v 1.1 in subjects with select tumor types by the Investigators [ 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 ]

Secondary Outcome Measures:
  • Phase 1A: Area under the plasma concentration-time curve (AUC) [ Time Frame: During first 4 months ]
  • Phase 1A: Maximum plasma concentration (Cmax) [ Time Frame: During first 4 months ]
  • Phase 1A: Time to reach maximum plasma concentration (Tmax) [ Time Frame: During first 4 months ]
  • Phase 1A: Terminal elimination half-life (t1/2) [ Time Frame: During first 4 months ]
  • Phase 1A: 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 ]
  • Phase 1A: 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 ]
  • Phase 1B: 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 ]
  • Phase 1B: 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 ]
  • Phase 1B: Plasma concentration [ Time Frame: During first 4 months ]

Enrollment: 451
Actual Study Start Date: June 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGB-A317 Phase 1A Biological: BGB-A317

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the schedule exploration part, patients will be assigned to doses and dose schedules. In the fix dose exploration, patients will be assigned to dose group(s) not to exceed the MTD.

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

Experimental: BGB-A317 Phase 1B Biological: BGB-A317
Patients will be assigned to different groups based on their tumor types

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

    1. For Phase 1A: no specific restriction
    2. For Phase 1B: histology specified below

    i. NSCLC (subjects with documented EGFR mutation or ALK rearrangement should be excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. TNBC viii. cholangiocarcinoma ix. RCC, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, GIST, or cuSCC. Or any other solid tumors with known MSI-H or dMMR status, such as CRC or pancreatic cancer

  2. Subjects with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids 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

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) except in patients with HCC, who meet the following criteria:

    • HBV viral load (VL) <200 IU/mL (approximately 1000 cps/mL)
    • Subjects with active HBV infection need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after
    • Subjects HCV-positive after successful treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug
  10. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407990


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
Oncology Consultants, P.A.
Houston, Texas, United States, 77024-2545
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Prince of Wales Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4216
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Australia, Victoria
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin Health Hospital
Heidelberg, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Nucleus Network
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research/Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 3080
Asan Medical Center
Seoul, Korea, Republic of, 5505
New Zealand
Auckland City Hospital
Grafton, New Zealand, 1023
Waikato
Hamilton, New Zealand, 3204
Wellington Hospital
Wellington, New Zealand, 6022
Taiwan
Chang Gung Memorial Hospital, Chiayi
Chiayi, Taiwan, 61363
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
National Taiwan University Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02407990     History of Changes
Other Study ID Numbers: BGB-A317_Study_001
First Submitted: March 26, 2015
First Posted: April 3, 2015
Last Update Posted: December 13, 2017
Last Verified: December 2017