Approval Probability
TA Base Rate
Adjusted LOA
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MP0317 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MP0317 + Gemcitabine + Cisplatin + Durvalumab | EXPERIMENTAL | MP0317- Gemcitabine+ Cisplatin + Durvalumab |
| Gemcitabine + Cisplatin + Durvalumab | ACTIVE_COMPARATOR | Gemcitabine + Cisplatin + Durvalumab |
| Name | Type | Description |
|---|---|---|
| MP0317 + Gemcitabine + Cisplatine + Durvalumab | DRUG | * 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-Scan | PROCEDURE | 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 + Durvalumab | DRUG | * 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. |
Inclusion Criteria: 1. Signed and dated informed consent 2. Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible) 3. Locally advanced unresectable or metastatic 4. Patient who had not previously received systemic a...
MP0317 is being developed for the first-line treatment of advanced biliary tract carcinoma, a group of cancers affecting the bile ducts and gallbladder. It is studied in combination with gemcitabine, cisplatin, and durvalumab in patients with this advanced disease. MP0317 remains investigational and has not been approved for any indication.
MP0317 targets both FAP and CD40. It is designed as a small molecule that engages fibroblast activation protein (FAP) and CD40, a co-stimulatory receptor on antigen-presenting cells. This dual targeting aims to activate immune responses within the tumor microenvironment in advanced biliary tract carcinoma.
MP0317 is being developed by Molecular Partners AG, a Swiss biopharmaceutical company listed on the SIX Swiss Exchange under the ticker MOLN. The company is advancing the asset in oncology, specifically for advanced biliary tract carcinoma.
MP0317 is in Phase 2 clinical development. The ongoing trial is a Phase 2 study evaluating MP0317 in combination with chemoimmunotherapy for first-line treatment of advanced biliary tract carcinoma. The drug is investigational and has not received regulatory approval.
MP0317 is being evaluated in a single Phase 2 trial, NCT07036380, titled "MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma." The trial is currently recruiting, with an estimated enrollment of 75 patients, and is being conducted in France.