About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β