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.
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;
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);
Single group
Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β
DrugTunlametinib + 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.
ORR
PFS
DCR
DOR
AEs
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This trial is not recruiting at the moment. You can still explore other options:
