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Advanced Biliary Tract CarcinomaPhase 2TACTICNCT07036380

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

A Phase 2 study testing MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan and Gemcitabine + Cisplatin + Durvalumab in people with Advanced Biliary Tract Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Biliary Tract Carcinoma
What is being tested?
MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan and Gemcitabine + Cisplatin + Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
11 sitesFrance
Study dates
22 Dec 2025to Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent
  • Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)
  • Locally advanced unresectable or metastatic
  • 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 (Response Evaluation Criteria In Solid Tumours) guidelines Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
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  • 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); with the exception of Grade 2 alopecia
  • Performance status ECOG-PS < 2 (Eastern Cooperative Oncology Group)
  • Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, and during treatment and at least 7 months after the end of the treatment with cisplatin, 6 months after the end of the treatment with gemcitabine, 3 months after the end of the treatment with durvalumab, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
  • Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.
  • Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
  • Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and at least: 4 months after the end of the treatment with cisplatin and 3 months after the end of the treatment with gemcitabine. Patients should refrain from donating sperm from the start of dosing until 4 months after discontinuing study treatment.
  • Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests:
  • For patients with active HBV: HBV DNA <500 IU/ml (International unit)during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir)
  • Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible
  • Patient affiliated to or beneficiary of French social security system
  • Ability to comply with the study protocol, in the Investigator's judgment.

Who cannot join

  • For patients whose tumors present a genetic alteration of IDH1, FGFR2 or BRAF as well as an amplification of HER2, the investigators of the TACTIC study recommend, if possible, the orientation for preferential inclusion in the SAFIR ABC10 study".
  • Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4) agent or any immune therapy
  • 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
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  • Other liver malignancy: hepatocellular carcinoma and hepato-cholangiocarcinoma
  • 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
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • History of angiocholitis, liver abscess, or acute pancreatitis within 4 weeks prior to initiation of study treatment
  • 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% (Left ventricular ejection fraction).
  • HIV (human immunodeficiency virus) 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). Replacement therapy (e.g. thyroxine, insulin) is allowed. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area,
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids,
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months,
  • 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 Note: Patients must agree not to receive live, attenuated influenza vaccine within 28 days prior to randomization, during treatment or within 5 months following the last dose of durvalumab
  • 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 (upper limit of normal), 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
  • Surgery within 4 weeks previously the initiation of the study treatment
  • Radiotherapy within 2 weeks previously the initiation of the study treatment
  • Patient with weight < 36 kg.
  • Pregnant or breastfeeding woman
  • Known hypersensitivity to components of MP0317, for exemple, histidine buffer or the Tween diluent, according to section 7.2 " Contraindications " of the Investigator's brochure of MP0317
  • Hypersensitivity to gemcitabine or to cisplatin, or to any of their excipients, according to the SmPCs of these products
  • According to the SmPC of cisplatin: hearing problem, in case of combination with phenytoin with prophylactic aim, patients with neuropathy caused by cisplatin, in case of cardiorespiratory pathology in particular, which forbids a hyperhydration

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christophe BORG, Pr contact

00 33 3 70 63 22 19

xtoph.borg@gmail.com

11 sites in 1 country

France11 sites, 11 recruiting

  • CHU de Besançon

    Besançon

    Christophe BORG, Pr

    Recruiting

  • Centre georges-François Leclerc

    Dijon

    François GHIRINGHELLI, Pr

    Recruiting

  • CHU de Grenoble

    Grenoble

    Gaël ROTH, Dr

    Recruiting

  • Centre Léon Bérard

    Lyon

    Philippe CASSIER, Dr

    Recruiting

  • CHU de Montpellier

    Montpellier

    Eric ASSENAT, Pr

    Recruiting

  • Hôpital Beaujon

    Paris

    Mohammed BOUATTOUR, Dr

    Recruiting

  • Hôpital La Pitié-Salpétrière

    Paris

    Jean-Baptiste BACHET, Pr

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Julien EDELINE, Pr

    Recruiting

  • Nouvel Hôpital Civil

    Strasbourg

    Antonio SAVIANO, Dr

    Not yet recruiting

  • CHU de Tours

    Tours

    Romain CHAUTARD, Dr

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Antoine HOLLEBECQUE, Pr

    Not yet recruiting

Other trials in France

About this study

Official title: 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 Radnomized Non-comparative Proof of Concept Phase II Study

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.

Being tested
MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan, Gemcitabine + Cisplatin + Durvalumab
Keywords
immunotherapy, DARPin, Advanced Biliary Tract Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP0317 + Gemcitabine + Cisplatine + DurvalumabDrug

    • 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.

  • CT-ScanProcedure or surgery

    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

  • Gemcitabine + Cisplatin + DurvalumabDrug

    • 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.
Study groups in NCT07036380
Study groupRoleWhat they receive
MP0317 + Gemcitabine + Cisplatin + DurvalumabExperimentalMP0317- Gemcitabine+ Cisplatin + Durvalumab
Receives: Drug: MP0317 + Gemcitabine + Cisplatine + Durvalumab; Procedure: CT-Scan
Gemcitabine + Cisplatin + DurvalumabActive comparatorGemcitabine + Cisplatin + Durvalumab
Receives: Procedure: CT-Scan; Drug: Gemcitabine + Cisplatin + Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival status (PFS) at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start22 Dec 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07036380
Sponsor's protocol ID
2024/926
Other IDs
2024-520029-35-00
Acronym
TACTIC
Status last verified
Nov 2026
First submitted
15 Jan 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan and Gemcitabine + Cisplatin + Durvalumab in people with Advanced Biliary Tract Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christophe BORG, Pr (00 33 3 70 63 22 19, xtoph.borg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival status (PFS) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07036380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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