Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
- Registration Number
- NCT05494762
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 55
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a: Dose Escalation Tislelizumab Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317) Phase 1b: Dose Expansion BGB-B167 BGB-B167 alone or in combination with tislelizumab (BGB-A317) Phase 1a: Dose Escalation BGB-B167 Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317) Phase 1b: Dose Expansion Tislelizumab BGB-B167 alone or in combination with tislelizumab (BGB-A317)
- Primary Outcome Measures
Name Time Method Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) Up to approximately 3 years Phase 1a: Number of Participants Experiencing Adverse Events (AEs) Up to approximately 3 years Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria Up to approximately 3 years Phase 1a: Maximum tolerated dose (MTD) Up to approximately 3 years MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Phase 1a: Recommended Phase 2 doses (RP2Ds) 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 1b: Objective Response Rate (ORR) 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 Outcome Measures
Name Time Method Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) 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 1a and 1b: Duration of Response (DOR) Up to approximately 3 years DOR is defined as the time from the first determination of a confirmed objective response until the first documentation of progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Phase 1a and 1b: Disease Control Rate (DCR) Up to approximately 3 years DCR is defined as the percentage of participants with best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167 Up to approximately 3 years Phase 1a: ORR 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 RECIST v1.1
Phase 1a and 1b: Clinical Benefit Rate (CBR) Up to approximately 3 years CBR is defined as the percentage of patients with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks, as determined by investigators per RECIST v1.1
Phase 1b: Progression-free Survival (PFS) Up to approximately 3 years PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
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 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
Trial Locations
- Locations (8)
Icon Cancer Centre Kurralta Park
🇦🇺Kurralta Park, South Australia, Australia
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Yale University, Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Tennessee Oncology, Pllc Nashville
🇺🇸Nashville, Tennessee, United States
Blacktown Cancer and Haematology Centre
🇦🇺Blacktown, New South Wales, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia