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Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies | Clinical Trials | Clareo Health

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Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies

A Cohort Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib Combined With Anti-EGFR Monoclonal Antibody in Patients With RAS-mutated Advanced Gastrointestinal Malignancies

NCT07446270•Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signing of written informed consent prior to enrolment;
•2. Age \> 18 years, males and females eligible;
•3. Patients with histologically or pathologically confirmed advanced pancreatic cancer or advanced colorectal cancer who have failed standard therapy;
•4. Genetic testing demonstrating RAS mutation;
•5. At least one measurable lesion according to RECIST v1.1 assessment;
•6. ECOG performance status: 0-1;
•7. Expected survival ≥ 3 months;
•8. Major organ function meets the following requirements:
•* Haemogram: Neutrophils ≥ 1.5 × 10⁹/L; Platelet count ≥ 90 × 10⁹/L; Haemoglobin ≥ 80 g/L; These haematological parameters must be maintained without the need for G-CSF, platelet or TPO transfusions, blood transfusions, or erythropoietin support therapy 14 days prior to the first dose.
•* Hepatic and renal function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 5 times ULN; Urine protein \<2+; if urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
+32 more criteria

Exclusion Criteria

•1. Known contraindications affecting the investigator's choice of therapeutic drug (as per the latest drug information leaflet)
•2. Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
•3. Major surgery (excluding biopsies or minor outpatient procedures such as vascular access placement) or severe trauma within 4 weeks prior to first dosing, or planned major surgery within 30 days after first dosing (as determined by the investigator);
•4. Presence of clinically symptomatic third-space effusions (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;

Key Dates

Start Date

March 3, 2026

Primary Completion Date

October 30, 2027

Completion Date

October 30, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Treatment for Advanced Colorectal CancerTreatment for Advanced Pancreatic Cancer

Interventions

Colorectal cancer: Tunlametinib + cetuximab β

DRUG

Pancreatic cancer: Tunlametinib + cetuximab β

DRUG

Pancreatic cancer: Tunlametinib +Nimotuzumab

DRUG