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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLuye Pharma Group Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Able to provide a signed informed consent;

Age ≥ 18 years and ≤ 75 years, both male and female;

Histologically confirmed metastatic colorectal cancer (CRC) with RAS mutation;

Disqualifiers

Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) who are suitable for immune checkpoint inhibitor therapy as assessed by the investigator;

Malignant tumors other than mCRC within 5 years before signing the informed consent;

Patients who did not recover from the AE of previous anti-tumor treatment to ≤ Grade 1;

Patients with body cavity effusion requiring local treatment or poorly controlled effusion;

Trial design

Treatments tested in this trial

  • LPM6690176
  • Bevacizumab
  • FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Treatment groups

99 Participants
are divided into 3 treatment groups

Sponsors and collaborators