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Trial record 1 of 1 for:    BGB-900-101
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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 : Active, not recruiting
First Posted : December 20, 2017
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BGB-A333 Drug: BGB-A333 and BGB-A317 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1A: BGB-A333 monotherapy dose escalation Drug: BGB-A333
Anti-PD-L1 antibody
Experimental: Phase 2A: BGB-A333 monotherapy dose expansion Drug: BGB-A333
Anti-PD-L1 antibody
Experimental: Phase 1B: BGB-A333 and BGB-A317 dose confirmation Drug: BGB-A333 and BGB-A317
Anti-PD-L1 and anti-PD-1 antibodies
Experimental: Phase 2B: BGB-A333 and BGB-A317 dose expansion Drug: BGB-A333 and BGB-A317
Anti-PD-L1 and anti-PD-1 antibodies


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: the number of Adverse Events [ Time Frame: up to 3 years ]
  2. Phase 1: The number of Serious Adverse Events [ Time Frame: up to 3 years ]
  3. Phase 1: the Maximum Tolerated Dose (MTD), if any, and Recommended Phase 2 dose (RP2D) [ Time Frame: up to 3 years ]
  4. Phase 2: Overall Response Rate (ORR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Phase 1: Overall Response Rate (ORR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  2. Phase 1: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  3. Phase 1: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  4. Phase 2: Duration of Response (DOR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  5. Phase 2: Progression-free Survival (PFS) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  6. Phase 2: Disease Control Rate (DCR) determined by investigators based on RECIST Version 1.1 [ Time Frame: up to 3 years ]
  7. Phase 2: the number of Adverse Events [ Time Frame: up to 3 years ]
  8. Phase 2: the number of Serious Adverse Events [ Time Frame: up to 3 years ]
  9. Phase 1 and Phase 2: Plasma concentrations of BGB-A333 [ Time Frame: up to 3 years ]
  10. Phase 1B and Phase 2B: Plasma concentrations of BGB-A317 [ Time Frame: up to 3 years ]
  11. Phase 1 and Phase 2: the percentage of participants who develop detectable anti-drug antibodies [ Time Frame: up to 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT03379259


Locations
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Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Nucleus Network
Melbourne, Victoria, Australia, 3004
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Linear Clinical Research
Perth, Western Australia, Australia, 6009
New Zealand
Auckland City Hospital
Grafton, New Zealand, 1023
Spain
Institut Catala d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
START Madrid. Fundacion Jimenez Diaz
Madrid, Spain, 28040
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Jayesh Desai, MD Peter MacCallum Cancer Centre, Australia
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03379259    
Other Study ID Numbers: BGB-900-101
2018-000265-37 ( EudraCT Number )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms