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Sponsor determined the data was no longer needed.
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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 in Chinese participants
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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) |
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| 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 with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Approximately 30 months | |
| Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | Up to Approximately 24 months | |
| Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167 | The maximum tolerated dose (MTD) is defined as the highest tolerated dose for which the estimated toxicity rate is closest to the target toxicity rate of 30%. | Approximately 30 months |
| 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 | Approximately 24 months |
| Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR). | Up to Approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: ORR | ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1. | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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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. |
| Up to Approximately 30 months |
| Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1. | DCR is defined as the proportion of participants with best overall response (BOR) of confirmed CR, PR, or stable disease | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1. | CBR is defined as the proportion of participants with BOR of confirmed CR, PR, or stable disease lasting ≥ 24 weeks. | Up to Approximately 30 months |
| Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1. | 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. | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a: Terminal half-life (t1/2) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a: Area Under the Plasma Concentration-time curve (AUC0-7d) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a: Clearance (CL) BGB-B167 | Up to Approximately 30 months |
| Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167 | Up to Approximately 30 months |
| Phase 1a and Phase 1b: Number of Participants with Anti-Drug Antibodies (ADAs) | Up to Approximately 30 months |
| Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Approximately 30 months |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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