Tunlametinib + AG + Cetuximab β as First-Line Therapy for Advanced Pancreatic Cancer

NCT07302841 | Not Yet Recruiting Phase 4

• 1 other identifier: IIT-085-ST-005
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of tunlametinib in combination with gemcitabine/albumin-bound paclitaxel and an EGFR monoclonal antibody as first-line therapy in treatment-naive subjects with advanced pancreatic cancer.

Conditions

Pancreatic Cancer Non-resectable

Keywords

first-line therapy in treatment; MEK inhibitor; AG; Tunlametinib; Cetuximab β

Outcome Measures

Primary Outcomes (1)

• ORR

  2 years

Secondary Outcomes (5)

• PFS

  2 years

• DCR

  2 years

• DOR

  2 years

• AEs

  2 years

• OS

  2 years

Study Arms (1)

Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β

EXPERIMENTAL

Drug: Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β

Interventions

Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β DRUG

Tunlametinib + Gemcitabine + Albumin Paclitaxel + Cetuximab β. The dosage of Tunlametinib capsules is 9 mg, taken orally twice a day (BID), continuously administered; the dosage of Gemcitabine is 1000 mg/m2, intravenous infusion for more than 30 minutes, on days 1 and 8; Albumin Paclitaxel, 125 mg/m2, intravenous infusion, on days 1 and 8, with a cycle every 3 weeks; Cetuximab β: 500 mg/m², intravenous infusion, on day 1, with the injection duration exceeding 2 hours but not more than 4 hours, administered once every 2 weeks.

Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing of a written informed consent form prior to enrolment;
• Age \> 18 years, males and females eligible;
• Patients with histologically or pathologically confirmed advanced pancreatic cancer;
• No prior systemic therapy;
• At least one measurable lesion according to RECIST v1.1 assessment;
• ECOG Performance Status: 0-1;
• Expected survival greater than 12 weeks;
• Major organ function meeting the following requirements:
• Haemogram: Neutrophils ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Haemoglobin ≥ 90 g/L; Maintenance of these haematological parameters without G-CSF, platelet transfusion, TPO infusion, blood transfusion, or erythropoietin support for 14 days prior to 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 agree to use one medically approved contraceptive method with their partner during the study treatment period and for 3 months after the study treatment period.
• Able to take oral medication;
• The subject voluntarily participates in this study, demonstrates good compliance, and cooperates with safety and survival follow-up.

You may not qualify if:

• Known contraindications affecting the investigator's choice of therapeutic agent (as per the latest prescribing information)
• Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
• Undergoing major surgery (excluding biopsy, minor outpatient procedures such as vascular access placement) or experiencing severe trauma within 4 weeks prior to first dosing, or having scheduled major surgery within 30 days after first dosing (as determined by the investigator);
• Previous receipt of anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nintedanib, panitumumab);
• Presence of clinically symptomatic third-space effusions uncontrollable by drainage or other methods (e.g., massive pleural effusion or ascites);
• Symptomatic or untreated brain metastases, leptomeningeal 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); Presence of RVO risk factors at screening (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED;
• Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring intervention);
• Known active pulmonary tuberculosis (TB); subjects suspected of active TB must undergo clinical evaluation to rule it 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Central Study Contacts

Rui Liu, MD

CONTACT

+86 13602139003; liurui9003@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12