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

Study acronym: TACTIC
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 4 of 11 sitesv4
  2. Site details revised at 3 of 11 sitesv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Jun 2025 to Dec 22, 2025
    • Primary completion date: Jun 2028 to Nov 2028
    • Study completion date: Jun 2029 to Nov 2029
    • Eligibility criteria expanded, about 177 words
    • Site details revised at 11 of 11 sites
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07036380
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators: Molecular Partners AG
Conditions
(from sponsor)		 Advanced Biliary Tract Carcinoma
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov