NCT07302841

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

A Clinical Study Evaluating the Efficacy and Safety of Tunlametinib in Combination With Chemotherapy and Cetuximab β in Patients With Advanced Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β	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.

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-06-20
• Completion: 2028-12-30
• First posted: 2025-12-24
• Last updated: 2025-12-24