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Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03379259
Recruitment Status : Terminated (Study Was Terminated Early)
First Posted : December 20, 2017
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE December 11, 2017
First Posted Date  ICMJE December 20, 2017
Last Update Posted Date May 10, 2021
Actual Study Start Date  ICMJE November 27, 2017
Actual Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
  • Phase 1: the number of Adverse Events [ Time Frame: up to 3 years ]
  • Phase 1: The number of Serious Adverse Events [ Time Frame: up to 3 years ]
  • Phase 1: the Maximum Tolerated Dose (MTD), if any, and Recommended Phase 2 dose (RP2D) [ Time Frame: up to 3 years ]
  • Phase 2: Overall Response Rate (ORR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • Phase 1: Overall Response Rate (ORR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 1: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 1: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Progression-free Survival (PFS) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: the number of Adverse Events [ Time Frame: up to 3 years ]
  • Phase 2: the number of Serious Adverse Events [ Time Frame: up to 3 years ]
  • Phase 1 and Phase 2: Plasma concentrations of BGB-A333 [ Time Frame: up to 3 years ]
  • Phase 1B and Phase 2B: Plasma concentrations of BGB-A317 [ Time Frame: up to 3 years ]
  • Phase 1 and Phase 2: the percentage of participants who develop detectable anti-drug antibodies [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
  • Phase 1: Overall Response Rate (ORR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 1: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 1: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Progression-free Survival (PFS) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  • Phase 2: the number of Adverse Events [ Time Frame: up to 3 years ]
  • Phase 2: the number of Serious Adverse Events [ Time Frame: up to 3 years ]
  • Phase 1 and Phase 2: Plasma concentrations of BGB-A333 [ Time Frame: up to 3 years ]
  • Phase 1B and Phase 2B: Plasma concentrations of BGB-A317 [ Time Frame: up to 3 years ]
  • Phase 1 and Phase 2: the percentage of patients who develop detectable anti-drug antibodies [ Time Frame: up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
Official Title  ICMJE Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Brief Summary BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death 1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1 (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tests the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in participants with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: BGB-A333
    Anti-PD-L1 antibody
  • Drug: BGB-A333 and BGB-A317
    Anti-PD-L1 and anti-PD-1 antibodies
Study Arms  ICMJE
  • Experimental: Phase 1A: BGB-A333 monotherapy dose escalation
    Intervention: Drug: BGB-A333
  • Experimental: Phase 2A: BGB-A333 monotherapy dose expansion
    Intervention: Drug: BGB-A333
  • Experimental: Phase 1B: BGB-A333 and BGB-A317 dose confirmation
    Intervention: Drug: BGB-A333 and BGB-A317
  • Experimental: Phase 2B: BGB-A333 and BGB-A317 dose expansion
    Intervention: Drug: BGB-A333 and BGB-A317
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 6, 2021)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2017)
156
Actual Study Completion Date  ICMJE September 8, 2020
Actual Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard therapy or for which treatment is not available, not tolerated or refused
  2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
  3. Has adequate organ function

Key Exclusion Criteria:

  1. Active brain or leptomeningeal metastasis.
  2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma)
  4. Concurrent participation in another therapeutic clinical trial.
  5. Received prior therapies targeting PD-1 or PD-L1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03379259
Other Study ID Numbers  ICMJE BGB-900-101
2018-000265-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jayesh Desai, MD Peter MacCallum Cancer Centre, Australia
PRS Account BeiGene
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP