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

Starting soon · Phase 2

Conditions studied: Treatment for Advanced Colorectal Cancer, Treatment for Advanced Pancreatic Cancer

In brief

Key facts

Study ID: NCT07446270
Run by: Chinese PLA General Hospital
People needed: 90
Starts: 2026-03-03
Expected to finish: 2028-10-30
Last updated by the study team: 2026-03-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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;
Creatine kinase (CK) ≤ 1.5 × ULN
Normal coagulation function with no active bleeding or thrombotic disorders: International Normalised Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN;
Non-surgically sterilised or female patients of childbearing potential must use one medically approved contraceptive method (e.g., intrauterine device, oral contraceptive, condom) during study treatment and for 3 months post-treatment. Non-surgically sterilised female patients of childbearing potential must have negative serum or urinary hCG tests within 7 days prior to study entry and must not be lactating. Male subjects who are not surgically sterilised or who are of reproductive age must consent to their spouse using a medically approved contraceptive method during the study treatment period and for 3 months after study treatment completion.
Able to take oral medication;
Subjects must voluntarily participate in this study, demonstrate good compliance, and cooperate with safety and survival follow-up.

You may not qualify if…

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);
Known active tuberculosis (TB); subjects suspected of active TB requiring clinical investigation to rule out; known active syphilis infection;
Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive with HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive with HBV DNA positive (HBsAg positive requires further testing for HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10³ copies/ml);
History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulators or surgery) within 12 months prior to treatment initiation;
Known history of acute or chronic pancreatitis within 6 months prior to study treatment initiation;
History of allogeneic bone marrow transplantation or organ transplantation;
Uncontrolled active infectious disease requiring intravenous antibiotics, antifungals, or antivirals within 2 weeks prior to first dosing, or unexplained fever >38.5°C during screening/prior to first dosing;
Uncorrectable electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia confirmed by serum biochemistry);
Past or current neuromuscular disorders associated with elevated CK levels (e.g., inflammatory myopathies, muscular dystrophies, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
Arterial or venous thromboembolic events occurring within 6 months prior to first administration, such as cerebrovascular accidents (including transient ischaemic attacks, cerebral haemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
Presence of oesophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or history of acute gastrointestinal haemorrhage within 6 months prior to first administration; occurrence of hypertensive crisis or hypertensive encephalopathy within 6 months prior to first administration; acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to first administration;
Grade 3 bleeding events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) within 4 weeks prior to first dose;
History of severe bleeding tendency or coagulation disorders; screening imaging demonstrating tumour encasement of major vessels or significant necrosis/cavitation where the investigator deems participation may pose a bleeding risk;
Current radiographic or clinical evidence of significant gastrointestinal obstruction;
Patients with a history of other malignancies within the past five years, except those with completely cured basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, and/or any malignancy that has been cured with no evidence of disease or at least five consecutive years of disease-free status;
Known hypersensitivity to any component of the study drug;
History of established neurological or psychiatric disorders, including epilepsy and dementia;
Failure of all relevant antineoplastic treatment toxicities to recover to Grade ≤1 (as assessed per NCI CTCAE V5.0) prior to study drug administration;

Full record on ClinicalTrials.gov

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