Phase II Study of MP0317 Combined with Gemcitabine, Cisplatin, and Durvalumab as First Treatment for Advanced Biliary Tract Cancer

What this Trial Is About

Researchers are investigating a new treatment approach for patients with advanced biliary tract carcinoma that cannot be removed by surgery. This phase II clinical trial aims to evaluate the clinical benefit and immune response of a combination therapy including MP0317, a CD40 agonist targeting Fibroblast Activation Protein, together with anti-PD-L1 therapy durvalumab and chemotherapy using gemcitabine and cisplatin. The study focuses on assessing progression-free survival over 12 months and includes translational research to understand molecular and immune factors affecting outcomes. Participants will be randomly assigned to one of two treatment groups the experimental group receiving MP0317 along with gemcitabine, cisplatin, and durvalumab, or the control group receiving gemcitabine, cisplatin, and durvalumab without MP0317. Treatment includes multiple cycles of immuno-chemotherapy administered intravenously every three weeks, followed by maintenance durvalumab given every four weeks until disease progression or unacceptable side effects occur. The trial includes a toxicity monitoring phase to ensure safety and tolerability of the experimental treatment. During the study, patients will undergo regular CT scans at baseline, every six weeks for the first 24 weeks, and then every eight weeks to monitor disease status. Researchers will also collect clinical and immunological data to evaluate treatment effects. The primary outcome is progression-free survival at 12 months. Overall participation lasts until disease progression or unacceptable toxicity, with ongoing safety assessments to protect patient well-being throughout the trial.

MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma