drugset / Trial / NCT06873763
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
NaSequentialOpen-labelTreatment
Summary
The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.
Timeline
- Start
- 2025-06-09
- Primary completion
- 2025-12
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nelmastobart | Monoclonal antibody | 800 mg | — |
| Subject | Trifluridine/Tipiracil | Unknown | 25 mg/m2 | — |
| Subject | Trifluridine/Tipiracil | Unknown | 30 mg/m2 | — |
| Subject | Trifluridine/Tipiracil | Unknown | 35 mg/m2 | — |
| Background | Bevacizumab | Monoclonal antibody | — | — |