NCT07036380

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

MP0317, a Tumor Targeting FAP Dependent CD40 Agonist DARPin, in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma: a Radnomized Non-comparative Proof of Concept Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the present TACTIC clinical trial, the investigators propose to determine the clinical interest and immunological efficacy of a treatment combining MP0317 the FAP (Fibroblast Activation Protein)-dependent CD40 agonist, with anti-PD-L1(Programmed Death-Ligand 1) therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy in unresectable cholangiocarcinoma. The main objective is to assess the 12-month progression free survival (PFS) rate in the experimental arm. The trial proposed is a non-comparative proof of concept randomized two-stage phase II. The control arm will serve to verify the good calibration of the null hypothesis made in the experimental arm and to provide "true" controls for translational investigations. A semi-continuous monitoring of toxicity is planned in the experimental arm during the first stage of the study to warrant the tolerability of the experimental treatment and then to guarantee the security of the patients. 75 patients (50 in the experimental arm) will be included. The investigators will also decipher, as a translational objective, the molecular and immunological parameters determining the clinical outcomes.

Conditions

• Advanced Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	MP0317 + Gemcitabine + Cisplatine + Durvalumab	* MP0317: 3 mg/kg IV(intraveinous), day 1, every 3 weeks for a maximum of 5 administrations * Immuno-chemotherapy (ICT): cycle 1-5 * Durvalumab 1500 mg IV, day 8 every 3 weeks * Gemcitabine 1000 mg/m² IV, days 8 and 15 every 3 weeks * Cisplatin 25 mg/m² IV, days 8 and 15 every 3 weeks * Immuno-chemotherapy (ICT): cycle 6-8 * Durvalumab 1500 mg IV every 3 weeks * Gemcitabine 1000 mg/m² at day 1, 8 every 21 days * Cisplatin 25 mg/m² at day 1, 8 every 21 days * Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity.
PROCEDURE	CT-Scan	at baseline, every 6 weeks (± 1 week) for the first 24 weeks and then every 8 weeks until progression, at end of treatment visit, At each follow-up visit : Only for patients who have not progressed during treatment phase
DRUG	Gemcitabine + Cisplatin + Durvalumab	* Immuno-chemotherapy (ICT) for 8 cycles : * Durvalumab 1500 mg IV, day 1 every 3 weeks * Gemcitabine 1000 mg/m² IV, days 1 and 8 every 3 weeks * Cisplatin 25 mg/m² IV, days 1 and 8 every 3 weeks * Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity.

Timeline

• Start date: 2025-12-22
• Primary completion: 2028-11-01
• Completion: 2029-11-01
• First posted: 2025-06-25
• Last updated: 2026-03-27

Locations

11 sites across 1 country: France