Actively Recruiting
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2026-03-27
75
Participants Needed
11
Research Sites
201 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Besancon
Lead Sponsor
M
Molecular Partners AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Histologically confirmed biliary tract carcinoma (intra/extrahepatic cholangiocarcinoma; gallbladder carcinoma excluded)
- Locally advanced unresectable or metastatic disease
- No prior systemic anti-cancer treatment (adjuvant Capecitabine allowed if completed at least 6 months ago)
- Age 18 years or older
- Measurable disease by RECIST v1.1 criteria
- Recovery from prior chemoembolization, radioembolization, or radiotherapy toxicities to grade 1 or less (except grade 2 alopecia)
- Eastern Cooperative Oncology Group performance status less than 2
- Females of childbearing potential must use effective contraception and have a negative pregnancy test; males must use barrier contraception
- Documented hepatitis B or C status as required, with controlled viral levels
- Affiliated with or beneficiary of French social security system
- Ability to comply with study protocol as judged by investigator
You will not qualify if you...
- Genetic alterations of IDH1, FGFR2, BRAF, or HER2 amplification recommended for other study inclusion
- Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA4, or any immunotherapy
- Additional malignancy diagnosed within past 3 years (except certain skin or cervical/breast cancers)
- Medical or psychiatric conditions unsuitable for study participation
- Current participation in another investigational study
- Under guardianship or legal protection
- Other liver malignancies such as hepatocellular carcinoma
- Uncontrolled pleural or pericardial effusion, ascites, or symptomatic fistula
- Uncontrolled tumor-related pain requiring steroids or frequent hospitalizations
- Active central nervous system metastases or carcinomatous meningitis
- Recent history (within 4 weeks) of angiocholitis, liver abscess, or acute pancreatitis
- Severe organ dysfunction including unstable heart failure, respiratory failure, infection, or oxygen dependency
- HIV positive or active tuberculosis
- Recent immunosuppressive therapy or active autoimmune disease requiring systemic treatment
- Prior allogeneic bone marrow or solid organ transplant
- Severe allergic reactions to monoclonal antibodies or durvalumab components
- Recent live attenuated vaccine use or planned use during study
- Inadequate blood counts, liver, kidney function, or serum albumin
- Recent major surgery or radiotherapy
- Weight less than 36 kg
- Pregnant or breastfeeding
- Known allergies to study drugs or components
- Hearing problems or neuropathy related to cisplatin that contraindicate treatment use
- Cardiorespiratory conditions forbidding hyperhydration with cisplatin treatment
AI-Screening
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Trial Site Locations
Total: 11 locations
1
CHU de Besançon
Besançon, France
Actively Recruiting
2
Centre georges-François Leclerc
Dijon, France
Actively Recruiting
3
CHU de Grenoble
Grenoble, France
Not Yet Recruiting
4
Centre Léon Bérard
Lyon, France
Not Yet Recruiting
5
CHU de Montpellier
Montpellier, France
Actively Recruiting
6
Hôpital Beaujon
Paris, France
Actively Recruiting
7
Hôpital La Pitié-Salpétrière
Paris, France
Not Yet Recruiting
8
Institut Curie
Paris, France
Not Yet Recruiting
9
Centre Eugène Marquis
Rennes, France
Not Yet Recruiting
10
CHU de Tours
Tours, France
Actively Recruiting
11
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
C
Christophe BORG, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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