Phase 12 Study of ABT-301 with Tislelizumab and Bevacizumab for Advanced pMMRNon-MSI-H Colorectal Cancer

What this Trial Is About

Researchers are studying the safety, tolerability, and best dosing of a drug called ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with a type of colorectal cancer called proficient mismatch repair pMMRnon-microsatellite instability-high non-MSI-H colorectal cancer. This study aims to find the highest safe dose of ABT-301 and the recommended dose for future studies while evaluating its effects in advanced or metastatic cases. Participants will take ABT-301 orally either once or twice daily in 21-day treatment cycles. Alongside ABT-301, participants will receive tislelizumab 200 mg and bevacizumab 7.5 mgkg via intravenous infusion on the first day of each 21-day cycle. The study has two parts a dose-escalation phase to identify safe dosing levels and a dose-optimization phase to further evaluate two selected doses for safety and activity against the cancer. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring safety and side effects, and pharmacokinetic and pharmacodynamic evaluations. These assessments occur from screening through treatment and up to 90 days after the last dose or until disease progression or death, lasting up to 28 months. The study monitors overall survival, progression-free survival, and duration of response to treatment.

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