drugset / Trial / NCT07244705
A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-11
- Primary completion
- 2028-04
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABT-301 | Unknown | 50 mg | Oral |
| Subject | ABT-301 | Unknown | 75 mg | Oral |
| Subject | ABT-301 | Unknown | 100 mg | Oral |
| Subject | ABT-301 | Unknown | 150 mg | Oral |
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |