A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

Phase 1a: ORR

ORR is defined as the percentage of participants with confirmed best overall response of CR or PR, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Time frame: From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 6 months

Phase 1b: Progression-Free Survival (PFS)

PFS is defined as the time from the first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.

Time frame: From first dose of study drug(s) until progressive disease or new anticancer treatment; approximately 12 months

Phase 1b: Number of Participants with AEs and SAEs

Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Special Interest (AESI) criteria.

Time frame: From first dose of the study drug(s) to 30 days after the last dose, or 90 days after last dose of tislelizumab; approximately 12 months

Phase 1a and 1b: Disease Control Rate (DCR)

DCR is defined as the percentage of participants who achieve confirmed CR, PR, or stable disease, as assessed by the investigator per RECIST Version 1.1.

Time frame: From first dose of study treatment drug(s) until confirmed response or stable disease; approximately 6 months for Phase 1a and 12 months for Phase 1b

Phase 1a and 1b: Duration of Response (DoR)

DoR is defined as the time from the first confirmed objective response to disease progression documented after treatment initiation or death, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.

Time frame: From confirmed response to disease progression or death; approximately 6 months for Phase 1a and 12 months for Phase 1b

Phase 1a and 1b: Serum Concentrations of BGB-B3227

Time frame: From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Ph1a and 12 months for Ph1b

Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BGB-B3227

Time frame: From first dose of BGB-B3227 up to 30 days after last dose of BGB-B3227; approximately 6 months for Phase 1a and 12 months for Phase 1b

Phase 1a: Area under the Curve (AUC) of BGB-B3227

Time frame: Approximately 4 months

Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-B3227

Time frame: Approximately 4 months

Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-B3227

Time frame: Approximately 4 months

Phase 1a: Trough concentration (Ctrough) of BGB-B3227

Time frame: Approximately 4 months

Phase 1a: Accumulation ratio of BGB-B3227

Time frame: Approximately 4 months

Phase 1a: Terminal half-life (t1/2) of BGB-B3227

Time frame: Approximately 4 months