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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Dose Escalation | Experimental | 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 | Experimental | BGB-B167 alone or in combination with tislelizumab (BGB-A317) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-B167 | Drug | Intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Number of Participants Experiencing Adverse Events (AEs) | Up to approximately 3 years | |
| Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) | 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) | MTD is defined as the highest tolerated dose with the target toxicity rate of 30% | Up to approximately 3 years |
| Phase 1a: Recommended Phase 2 doses (RP2Ds) | RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose | Up to 90 days after the last dose of study drug(s); up to approximately 3 years |
| Phase 1b: Objective Response Rate (ORR) | 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 | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: ORR | 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 | Up to approximately 3 years |
| Phase 1a and 1b: Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-3012 | United States | ||
| Yale University, Yale Cancer Center |
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2026 | |
| Unrelease | Jun 1, 2026 |
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| Tislelizumab | Drug | Intravenous administration |
|
|
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
| Up to approximately 3 years |
| Phase 1a and 1b: Disease Control Rate (DCR) | 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 | Up to approximately 3 years |
| Phase 1a and 1b: Clinical Benefit Rate (CBR) | 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 | Up to approximately 3 years |
| Phase 1b: Progression-free Survival (PFS) | 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 | Up to approximately 3 years |
| Phase 1a and 1b: Serum Concentration of Tislelizumab | 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: Minimum observed serum concentration (Cmin) of BGB-B167 | 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 |
| Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167 | 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: Number of Participants with Antidrug Antibodies (ADAs) | Up to approximately 3 years |
| New Haven |
| Connecticut |
| 06520-8028 |
| United States |
| Tennessee Oncology, Pllc Nashville | Nashville | Tennessee | 37203-1619 | United States |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | 2148 | Australia |
| Icon Cancer Centre Kurralta Park | Kurralta Park | South Australia | 5037 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 1, 2026 |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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