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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2029

Conditions
Advanced Biliary Tract Carcinoma
Interventions
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."

Trial Locations (11)

Unknown

CHU de Besançon, Besançon

Centre georges-François Leclerc, Dijon

CHU de Grenoble, Grenoble

Centre Léon Bérard, Lyon

CHU de Montpellier, Montpellier

Hôpital Beaujon, Paris

Hôpital La Pitié-Salpétrière, Paris

Institut Curie, Paris

Centre Eugène Marquis, Rennes

CHU de Tours, Tours

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Molecular Partners AG

INDUSTRY

lead

Centre Hospitalier Universitaire de Besancon

OTHER