Not Yet RecruitingPhase 2

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

90 participantsStarted 2026-03-03

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Signing of written informed consent prior to enrolment;
✓. Age \> 18 years, males and females eligible;
✓. Patients with histologically or pathologically confirmed advanced pancreatic cancer or advanced colorectal cancer who have failed standard therapy;
✓. Genetic testing demonstrating RAS mutation;
✓. At least one measurable lesion according to RECIST v1.1 assessment;
✓. ECOG performance status: 0-1;
✓. Expected survival ≥ 3 months;
✓. Major organ function meets the following requirements:

Exclusion criteria

✕. Known contraindications affecting the investigator's choice of therapeutic drug (as per the latest drug information leaflet)
✕. Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
✕. 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);
✕. Presence of clinically symptomatic third-space effusions (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;
✕. Symptomatic or untreated brain metastases, meningeal metastases, or spinal cord compression, except for: Asymptomatic brain metastases (i.e., no progressive CNS symptoms attributable to brain lesions, no requirement for corticosteroids or antiepileptic drugs, and imaging confirmation of stable disease for ≥4 weeks); Patients undergoing stereotactic brain radiotherapy or surgery may be eligible if no disease progression is observed in the brain over a period of ≥3 months;
✕. Cardiac impairment or clinically significant cardiovascular disease with uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
✕. History or presence at screening of retinal disease, including: retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillaropathy (Costs disease), retinal pigment epithelial detachment (RPED), etc.; Screening for risk factors of RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED;
✕. Interstitial lung disease or interstitial pneumonia, including patients with clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring intervention);

What they're measuring

ORR

Timeframe: 2 years

Trial details

NCT IDNCT07446270

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30

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