Trial Identifiers
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Scientific Title
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Commercial Sponsor
BeiGene Australia Pty Ltd
Summary
This study has two phases. In Phase 1b, participants will receive LBL-007 + tislelizumab + bevacizumab + capecitabine in a modified 3+3 scheme that will evaluate LBL-007 in 2 dose levels. In the second phase, there are five experimental arms and eligible participants will be randomly allocated. Experimental Arm A will recruit Protein Ligand -1 (PD-L1) Positive participants, and they will receive LBL-007 + tislelizumab + bevacizumab + capecitabine. Experimental Arm B will recruit PD-L1 Positive participants, who will receive LBL-007 + bevacizumab + capecitabine. Experimental Arm C will recruit PD-L1 Positive participants, who will receive bevacizumab + capecitabine. Experimental Arm D will recruit PD-L1 Negative participants, who will receive LBL-007 + tislelizumab + bevacizumab + capecitabine. Experimental Arm E will recruit PD-L1 Negative participants, who will receive bevacizumab + capecitabine. LBL-007 will be administered once every 3 weeks intravenously. Tislelizumab will be administered at a dose of 300mg intravenously once every 3 weeks. Bevacizumab will be administered at a dose of 7.5mg/kg intravenously once every 3 weeks. Capecitabine will be administered at a dose of 1000mg/m^2 twice daily orally on days 1 to 14 of each 21-day treatment cycle.