A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg/kg IV infusion Q3W, in participants with pMMR/non-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301. Participants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg/kg IV Q3W will be given in both parts of the study.

NCT Number	NCT07244705
Lead Sponsor	Anbogen Therapeutics, Inc. Collaborators: Fortrea
Conditions	Colorectal Cancer (Diagnosis), Colorectal Cancer Metastatic, Colorectal Cancer (CRC), Immunotherapy
Enrollment	66 participants
Start Date	2025-11
Primary Completion	2028-04 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2025-11-24