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Treatment for Advanced Colorectal CancerPhase 2NCT07446270

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

A Phase 2 study testing Colorectal cancer: Tunlametinib + cetuximab β, Pancreatic cancer: Tunlametinib + cetuximab β and Pancreatic cancer: Tunlametinib +Nimotuzumab in people with Treatment for Advanced Colorectal Cancer and Treatment for Advanced Pancreatic Cancer, run by Chinese PLA General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Colorectal cancer: Tunlametinib + cetuximab β, Pancreatic cancer: Tunlametinib + cetuximab β and Pancreatic cancer: Tunlametinib +Nimotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
3 Mar 2026to 30 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Concurrent use of other antineoplastic agents for concomitant treatment (bisphosphonates for bone metastases are acceptable);
  • Uncontrolled concomitant conditions, including but not limited to severe diabetes mellitus (fasting blood glucose > 250 mg/dl or 13.9 mmol/L) or other serious illnesses requiring systemic treatment;
  • Administration of live or attenuated vaccines within 4 weeks prior to first study dose (Note: If enrolled, subjects must not receive live vaccines during study treatment or within 30 days after the last study dose); ;
  • Positive pregnancy test result in premenopausal female subjects (postmenopausal female subjects must have been amenorrheic for at least 12 months to be considered non-fertile); subjects of reproductive age (including female partners of male subjects) who are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study period and for at least 30 days after the last dose of study medication;
  • Patients currently receiving intravenous or oral medications that are prohibited by the protocol due to their effects on CYP isoenzymes (strong inducers or inhibitors of CYP2C9 and CYP3A4) and cannot be discontinued at least one week prior to study treatment initiation and throughout the study period; patients taking narrow therapeutic index medications metabolised via CYP1A2;
  • Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, extrahepatic bile diversion, or significant small bowel resection that may impair adequate absorption of the study drug;
  • Other conditions deemed ineligible by the investigator. For example, familial or social factors that may compromise subject safety or the collection of data and samples.

About this study

Official title: 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

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

Being tested
Colorectal cancer: Tunlametinib + cetuximab β, Pancreatic cancer: Tunlametinib + cetuximab β, Pancreatic cancer: Tunlametinib +Nimotuzumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colorectal cancer: Tunlametinib + cetuximab βDrug

    Colorectal cancer: Tunlametinib 6/9mg bid+ cetuximab β 500mg/m2

  • Pancreatic cancer: Tunlametinib + cetuximab βDrug

    Pancreatic cancer: Tunlametinib 6/9mg+ cetuximab β 500mg/m2

  • Pancreatic cancer: Tunlametinib +NimotuzumabDrug

    Pancreatic cancer: Tunlametinib 6/9mg bid +Nimotuzumab 400mg

Study groups in NCT07446270
Study groupRoleWhat they receive
Colorectal cancer: Tunlametinib + cetuximab βExperimentalNot described
Receives: Drug: Colorectal cancer: Tunlametinib + cetuximab β
Pancreatic cancer: Tunlametinib + cetuximab βExperimentalNot described
Receives: Drug: Pancreatic cancer: Tunlametinib + cetuximab β
Pancreatic cancer: Tunlametinib + NimotuzumabExperimentalNot described
Receives: Drug: Pancreatic cancer: Tunlametinib +Nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Measured: 2 years

Secondary outcomes (5)

  1. PFS

    Measured: 2 years

  2. DCR

    Measured: 2 years

  3. DOR

    Measured: 2 years

  4. OS

    Measured: 2 years

  5. AEs

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start3 Mar 2026 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07446270
Sponsor's protocol ID
IIT-085-ST-003
Status last verified
Feb 2026
First submitted
26 Feb 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colorectal cancer: Tunlametinib + cetuximab β, Pancreatic cancer: Tunlametinib + cetuximab β and Pancreatic cancer: Tunlametinib +Nimotuzumab in people with Treatment for Advanced Colorectal Cancer and Treatment for Advanced Pancreatic Cancer, run by Chinese PLA General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07446270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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