NCT07391566

LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation

Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LPM6690176 Capsules in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	LPM6690176	LPM6690176 orally.
BIOLOGICAL	Bevacizumab	Bevacizumab intravenously
DRUG	FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)	FOLFIRI intravenously

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China