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

ConditionMetastatic Colorectal Cancer (mCRC)
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LPM6690176

    Drug

    LPM6690176 orally.

  • Bevacizumab

    Biological/Vaccine

    Bevacizumab intravenously

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

    Drug

    FOLFIRI intravenously

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: LPM6690176 24 mg/m2Experimental treatment 3 interventions
Group B: LPM6690176 36 mg/m2Experimental treatment 3 interventions
Group C: LPM6690176 42 mg/m2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase Ib: Dose-limiting toxicities (DLTs)

Time frame
From the first dose of study drug treatment through Cycle 1 (28 days)
2

Phase Ib: Maximum tolerated dose (MTD)

Time frame
From the first dose of study drug treatment through Cycle 1 (28 days)
3

Phase 1b: Recommended Phase 2 Dose (RP2D)

Time frame
From the first dose of study drug treatment through Cycle 1 (28 days)
4

Phase 2: Overall response rate (ORR)

Time frame
Approximately 2 years

Secondary outcomes

1

Phase 1b: Overall response rate (ORR)

Time frame
Approximately 2 years
2

Duration of response (DOR)

Time frame
Approximately 2 years
3

Disease control rate (DCR)

Time frame
Approximately 2 years
4

Progression-free survival (PFS)

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luye Pharma Group Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: