A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- BGB-B167
- Conditions
- Solid Tumor
- Sponsor
- BeiGene
- Enrollment
- 55
- Locations
- 8
- Primary Endpoint
- Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 or older
- •Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)
Exclusion Criteria
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- •History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
- •Women who are pregnant or are breastfeeding
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
Intervention: BGB-B167
Phase 1a: Dose Escalation
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
Intervention: BGB-B167
Phase 1a: Dose Escalation
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
Intervention: Tislelizumab
Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
Intervention: Tislelizumab
Outcomes
Primary Outcomes
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 3 years
Phase 1a: Recommended Phase 2 doses (RP2Ds)
Time Frame: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Time Frame: Up to approximately 3 years
Phase 1a: Maximum tolerated dose (MTD)
Time Frame: Up to approximately 3 years
MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Phase 1b: Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcomes
- Phase 1a and 1b: Duration of Response (DOR)(Up to approximately 3 years)
- Phase 1a and 1b: Disease Control Rate (DCR)(Up to approximately 3 years)
- Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)(Up to approximately 3 years)
- Phase 1a: ORR(Up to approximately 3 years)
- Phase 1a and 1b: Clinical Benefit Rate (CBR)(Up to approximately 3 years)
- Phase 1b: Progression-free Survival (PFS)(Up to approximately 3 years)
- Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Serum Concentration of Tislelizumab(Up to approximately 3 years)
- Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Total body clearance (CL) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167(Up to approximately 3 years)
- Phase 1b: Number of Participants with AEs or SAEs(Up to approximately 3 years)
- Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167(Up to approximately 3 years)