A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors

Phase 1a: Time to Response (TTR)

TTR is defined as the time from the date of the first dose of study drug(s) to the date of the first determination of overall response by the investigator using RECIST v1.1

Time frame: Up to approximately 2 years

Phase 1a: Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks

Time frame: Up to approximately 2 years

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

DOR is defined as the time from the first objective response until the first documentation of disease progression after treatment initiation or death, whichever comes first, as determined by investigators per RECIST v1.1

Time frame: Up to approximately 2 years

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

DCR is defined as the percentage of participants with the best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1

Time frame: Up to approximately 2 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

Time frame: Up to approximately 2 years

Phase 1b: Number of Participants with Adverse Events (AEs)

Number of participants with AEs, including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings, physical examination, or electrocardiogram results), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by NCI-CTCAE V5.0 or ASTCT as appropriate

Time frame: Up to approximately 2 years

Phase 1a: Plasma concentrations of BGB-R046 analytes

Time frame: Predose and at select time points in Cycles 1, 2 and 5; predose at select Cycles between Cycles 3 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)

Phase 1b: Plasma concentrations of BGB-R046 analytes

Time frame: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)

Phase 1b: Plasma concentrations of tislelizumab

Time frame: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 17 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)

Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-R046

Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)

Phase 1a and 1b: Minimum Observed Plasma Concentration (Ctrough) Of BGB-R046

Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)

Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BGB-R046

Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)

Phase 1a and 1b: Terminal Half-Life (t1/2) of BGB-R046

Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)

Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-R046 and tislelizumab

Time frame: Periodic sampling up to Cycle 25 (each cycle is 21 days) and at the first safety follow up visit up to approximately 2 years (conducted 30 days after the last dose of study drug)