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

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT07391566
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer (mCRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
99 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LPM6690176 24 mg/m2
    LPM6690176 capsules administered 24 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab
  • Experimental: LPM6690176 36 mg/m2
    LPM6690176 capsules administered 36 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab
  • Experimental: LPM6690176 42 mg/m2
    LPM6690176 capsules administered 42 mg/m2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with FOLFIRI+Bevacizumab

Primary Outcome Measure

Phase Ib: Dose-limiting toxicities (DLTs) [ Time Frame: From the first dose of study drug treatment through Cycle 1 (28 days) ]

Central Contacts

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