drugset / Trial / NCT07649655
EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.
Timeline
- Start
- 2026-07
- Primary completion
- 2028-03-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAFISONTAMAB | Monoclonal antibody | — | — |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | TAS-102 | Small molecule | — | Oral |
| Subject | fluorouracil | Small molecule | — | Intravenous |