Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Futibatinib · 1 trial · 1 indication
Time from randomisation to the first documented progression of disease (PD) as assessed by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Molecular targeted therapy matched to genetic alteration carried by the tumour |
| Control | ACTIVE_COMPARATOR | Continued standard of care treatment for first-line biliary tract cancer |
| Name | Type | Description |
|---|---|---|
| Futibatinib | DRUG | Dose 20 mg once a day (QD) |
| Ivosidenib | DRUG | Dose 500 mg QD |
| Zanidatamab | DRUG | Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W |
| Trastuzumab | DRUG | Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib) |
| Neratinib | DRUG | Dose: 240 mg QD (combination with trastuzumab) |
| Encorafenib | DRUG | Dose: 450 mg QD (Combination with binimetinib) |
| Binimetinib | DRUG | Dose: 45 mg twice a day (BID) (Combination with encorafenib) |
| Niraparib | DRUG | Dose: 200 mg QD or 300 mg QD |
| Cisplatin | DRUG | Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM) |
| Gemcitabine | DRUG | Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM) |
SCREENING PHASE Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures (Consent #1) 2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded) 3. De novo or recurrent, locally ...
Futibatinib is an investigational small molecule being studied for the treatment of Biliary Tract Neoplasms, which are cancers of the bile ducts and gallbladder. It is currently in Phase 3 clinical development as part of a personalized medicine approach for advanced biliary cancer patients.
Futibatinib targets fibroblast growth factor receptors (FGFR), specifically FGFR1, FGFR2, FGFR3, and FGFR4. It acts as an inhibitor of these receptors, which are involved in cell growth and proliferation. By inhibiting FGFR signaling, Futibatinib aims to slow or stop the growth of biliary tract cancer cells.
Futibatinib is being developed by Zymeworks Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ZYME. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with biliary tract cancers.
Futibatinib is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess its effectiveness compared to an active control in patients with advanced biliary cancer.
Futibatinib is being evaluated in a Phase 3 clinical trial registered as NCT05615818, titled 'Personalized Medicine for Advanced Biliary Cancer Patients.' This randomized, active-controlled study is recruiting 800 participants across Belgium, France, and the United Kingdom. The trial is open to adults aged 18 years and older.
No alternative names for Futibatinib have been reported. It is identified by its chemical name and the ChEMBL identifier CHEMBL3701238. The drug is being developed under the name Futibatinib by Zymeworks Inc. and is not known to be marketed under any other brand name.