Actively Recruiting
MP0317, a Tumor Targeting FAP Dependent CD40 Agonist DARPin, Combined With Chemoimmunotherapy for First Line Treatment of Advanced Biliary Tract Carcinoma: A Randomized Non-comparative Proof of Concept Phase II Study
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2026-06-01
75
Participants Needed
11
Research Sites
52 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
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.
CONDITIONS
Brief 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 (intrahepatic or extrahepatic cholangiocarcinoma), excluding gallbladder carcinoma
- Locally advanced unresectable or metastatic disease
- No previous systemic anti-cancer treatment (adjuvant Capecitabine allowed if completed at least 6 months prior)
- Age 18 years or older
- Measurable disease as defined by RECIST v1.1
- Recovery from prior chemoembolization, radioembolization, or radiotherapy toxicity to grade 1 or less (except grade 2 alopecia)
- ECOG performance status less than 2
- Women of childbearing potential using effective contraception with negative pregnancy test or evidence of non-childbearing potential
- Documented hepatitis B or C status with controlled viral load if applicable
- Affiliated with or beneficiary of French social security
- 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 alternate study inclusion
- Prior anti-tumor immunotherapy including anti-PD-1, anti-PD-L1, or anti-CTLA4 agents
- Additional malignancy within 3 years except certain skin or cervical/breast cancers
- Medical or psychiatric conditions unsuitable for study entry
- Current participation in another investigational study
- Under legal guardianship or protection
- Other liver malignancies such as hepatocellular carcinoma or hepato-cholangiocarcinoma
- Uncontrolled pleural or pericardial effusion, ascites, or symptomatic fistula
- Uncontrolled tumor-related pain requiring corticosteroids or hospitalization
- Active central nervous system metastases or carcinomatous meningitis
- Recent history (within 4 weeks) of angiocholitis, liver abscess, or acute pancreatitis
- Inadequate organ functions including cardiac, respiratory, or infection risks
- HIV positive or active tuberculosis
- Recent immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment in past 2 years with exceptions
- Prior bone marrow or solid organ transplantation
- Severe allergic reactions to relevant antibodies or proteins
- Hypersensitivity to durvalumab components or study drugs
- Recent live attenuated vaccination
- Hematology, liver, kidney function below specified thresholds
- Recent surgery or radiotherapy
- Weight under 36 kg
- Pregnant or breastfeeding women
- Hypersensitivity to MP0317, gemcitabine, or cisplatin or related excipients
- Specific hearing, neuropathy, or cardiorespiratory contraindications to cisplatin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks for initial 8 cycles of chemotherapy and immunotherapy, followed by ongoing durvalumab monotherapy maintenance until disease progression or unacceptable toxicity
Participants receive MP0317 combined with gemcitabine, cisplatin, and durvalumab or gemcitabine, cisplatin, and durvalumab alone as first line treatment for advanced biliary tract carcinoma.
Treatment visits every 3 weeks for up to 8 cycles, then durvalumab monotherapy every 4 weeks
Duration - Baseline, every 6 weeks for first 24 weeks, then every 8 weeks until disease progression
Participants undergo regular CT scans to monitor disease status during and after treatment.
Imaging visits every 6 weeks for 24 weeks, then every 8 weeks
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
Actively Recruiting
4
Centre Léon Bérard
Lyon, France
Actively Recruiting
5
CHU de Montpellier
Montpellier, France
Actively Recruiting
6
Hôpital Beaujon
Paris, France
Actively Recruiting
7
Hôpital La Pitié-Salpétrière
Paris, France
Actively Recruiting
8
Institut Curie
Paris, France
Not Yet Recruiting
9
Centre Eugène Marquis
Rennes, France
Actively Recruiting
10
CHU de Tours
Tours, France
Actively Recruiting
11
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
C
Christophe BORG, Pr
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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