drugset / Trial / NCT07391566
LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and Bevacizumab in patients with RAS mutant metastatic colorectal cancer (mCRC), to observe the dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D); Phase 2 is planned to preliminarily evaluate the efficacy of LPM6690176 capsule in combination with chemotherapy + Bev vs. chemotherapy + Bev in patients with previously untreated, RAS mutant mCRC.
Timeline
- Start
- 2026-03-31
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LPM6690176 | Unknown | 24 mg/m2 | Oral |
| Subject | LPM6690176 | Unknown | 36 mg/m2 | Oral |
| Subject | LPM6690176 | Unknown | 42 mg/m2 | Oral |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Irinotecan | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |