This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.
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Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab
Timeframe: Up to 28 days
Phase 1: Recommended Phase 2 Dose (RP2D) of Surzebiclimab in Combination With Tislelizumab
Timeframe: Up to 28 days
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs
Timeframe: Up to 30 days after last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Tislelizumab
Timeframe: Up to 21 days
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Surzebiclimab and Tislelizumab
Timeframe: Up to 21 days
Phase 2 (Safety Lead-In): RP2D of Alcestobart in Combination With Surzebiclimab and Tislelizumab
Timeframe: Up to 21 days
Phase 2 (Dose Expansion): Overall Response Rate (ORR)
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 months