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TACTIC : 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 RANDOMIZED NON COMPARATIVE PROOF OF CONCEPT PHASE II STUDY
EU CTIS ID: 2024-520029-35-01
What this study is testing
To assess the efficacy of a strategy combining MP0317 and durvalumab plus gemcitabine/cisplatin (experimental arm) in terms of progression free rate at 12 months according to RECIST v1.1.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent
- Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests
- Patient affiliated to or beneficiary of French social security system
- Ability to comply with the study protocol, in the Investigator’s judgment
- Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)
- Locally advanced, metastatic, or unresectable disease
You likely can't join if
- Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy
- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
- Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition. Patients requiring oxygen therapy or with LEVF<40%.
- HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus
- Any immunosuppressive therapy (i.e. corticosteroids >10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy
See the full eligibility criteria
Who can join
- Signed and dated informed consent
- Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests
- Patient affiliated to or beneficiary of French social security system
- Ability to comply with the study protocol, in the Investigator’s judgment
- Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)
- Locally advanced, metastatic, or unresectable disease
- Patient who had not previously received systemic anti-cancer treatment (adjuvant treatment with Capecitabine is allowed if the end of the chemotherapy was at least 6 months ago)
- Age ≥ 18 years
- Measurable disease defined according to RECIST v1.1 guidelines (Annex 2) Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
- Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 5 (CTCAE v5) (Annex 5); with the exception of Grade 2 alopecia
- Performance status ECOG-PS < 2
- Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening
What rules you out
- Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy
- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
- Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition. Patients requiring oxygen therapy or with LEVF<40%.
- HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus
- Any immunosuppressive therapy (i.e. corticosteroids >10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy
- Active autoimmune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroids or immunosuppressive drugs).
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of durvalumab
- Receipt of a live, attenuated vaccine within 30 days prior to inclusion or anticipation that such a live, attenuated vaccine will be required during the study
- Known active central nervous system metastases and/or carcinomatous meningitis
- Inadequate hematology function: Lymphocyte count at baseline < 700/mm3; neutrophil count < 1 500/mm3, platelets < 10 0000/mm3 (without transfusion), Hemoglobin < 9g/dL (patients may be transfused to meet this criterion).
- Inadequate hepatic function: bilirubin >2 fold ULN, AST/ALT >3 fold ULN, International normalized thromboplastin time ratio >2
- Creatinine clearance (CrCl) < 60 ml/min (by the Modification of Diet in Renal Disease [MDRD], Cockroft formula, or chronic kidney disease [CKD] formula])
- Serum albumin < 28 g/L
- History of angiocholitis, liver abscess, or acute pancreatitis within 4 weeks prior to initiation of study treatment
- Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Current participation in a study of an investigational agent or in the period of exclusion
- Patient under guardianship, curatorship or under the protection of justice
- Other liver malignancy: hepatocellular carcinoma and hepato-cholangiocarcinoma
- Cholangiocarcinoma displaying IDH1 mutations, FGFR2 fusions, BRAF mutations or HER2 amplification
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.