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Not yet recruiting NCT07391566

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

Phase I / Phase II Interventional Metastatic Colorectal Cancer (mCRC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LPM6690176, Bevacizumab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan).
Who it may be relevant to
Registry conditions: Metastatic Colorectal Cancer (mCRC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug LPM6690176
    LPM6690176 orally.
  • Biological Bevacizumab
    Bevacizumab intravenously
  • Drug FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
    FOLFIRI intravenously

Primary outcome measures

  • Phase Ib: Dose-limiting toxicities (DLTs) [Time frame: From the first dose of study drug treatment through Cycle 1 (28 days)]
  • Phase Ib: Maximum tolerated dose (MTD) [Time frame: From the first dose of study drug treatment through Cycle 1 (28 days)]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) [Time frame: From the first dose of study drug treatment through Cycle 1 (28 days)]
  • Phase 2: Overall response rate (ORR) [Time frame: Approximately 2 years]
Secondary outcome measures (11)
  • Phase 1b: Overall response rate (ORR) [Time frame: Approximately 2 years]
  • Duration of response (DOR) [Time frame: Approximately 2 years]
  • Disease control rate (DCR) [Time frame: Approximately 2 years]
  • Progression-free survival (PFS) [Time frame: Approximately 2 years]
  • Overall survival (OS) [Time frame: Approximately 2 years]
  • Maximum plasma concentration (Cmax) [Time frame: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)]
  • Time to maximum plasma concentration (Tmax) [Time frame: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)]
  • Area under the plasma concentration-time curve (AUC) [Time frame: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)]
  • Elimination half-life (t1/2) [Time frame: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 9 (Approximately 10 days, each cycle is 28 days)]
  • Trough observed plasma concentration (Ctrough) [Time frame: From Pre-dose of Cycle 1 Day 1 and up to Cycle 1 Day 19 (Approximately 20 days, each cycle is 28 days)]
  • Adverse Events (AEs) [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

  • 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;
  • Prior therapies for colorectal cancer:

(1 ) For phase 1b patients: who have failed or intolerable to prior first-line therapy; (2) For phase 2 patients: who have not received prior systemic therapy for metastatic colorectal cancer.

5\. At least one measurable lesion according to RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 7. Life expectancy≥ 6 months; 8. Adequate bone marrow and organ function; 9. Negative pregnancy test for women of childbearing potential. patients of childbearing potential should take effective contraceptive measures during study drug treatment and until 6 months after initiation of investigational product.

Exclusion criteria

  • 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;
  • Symptomatic brain metastasis, history of spinal cord compression or meningeal metastasis;
  • Underwent other therapeutic surgery other than diagnosis, biopsy, drainage, or expected to require major surgery during the study, or had unhealed wound, ulcer or fracture.
  • Current or previous uncontrolled concomitant non-gastrointestinal disease including, but not limited to myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, serious arrhythmia, current uncontrolled hypertension, previous history of hypertensive crisis or hypertensive brain disease, tumor invasion into major blood vessels, interstitial lung disease, interstitial pneumonia, pulmonary interstitial fibrosis, reversible posterior leukoencephalopathy syndrome (RPLS), etc.;
  • Current or past presence of the gastrointestinal abnormalities, including but not limited to active peptic ulcer, clinically significant gastrointestinal abnormalities prior to informed consent, active colitis, long-term anticoagulant therapy, antiplatelet therapy, etc.;
  • Current or past significant risk of bleeding;
  • Use of prohibited medication or therapy within the specified time;
  • History of drug abuse or alcoholism;
  • Known hypersensitivity to any component of any investigational product;
  • Pregnant and lactating women;
  • Other conditions that may increase the risk of the study or interfere with study results, in the judgment of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07391566 · LY01024/CT-CHN-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗