LIBERTY-201: This phase I/II study is investigating how safe and effective LBL-007 plus Tislelizumab is when given in combination with targeted therapy (bevacizumab) and chemotherapy (capecitabine), compared to bevacizumab + capecitabine alone, in people with bowel cancerA 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

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.

Conditions

This trial is treating patients with microsatellite stable/mismatch repair proficient colorectal cancer

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