Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zanidatamab · 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 ...
Zanidatamab is an investigational monoclonal antibody being studied for the treatment of biliary tract neoplasms, a group of cancers affecting the bile ducts and gallbladder. It is in Phase 3 clinical development and has received a PRIORITY_REVIEW designation from the FDA. It is not yet approved for commercial use.
Zanidatamab targets ERBB2, also known as HER2, a receptor tyrosine kinase that is overexpressed in certain cancers. As an ERBB2 inhibitor, it is designed to bind to this target and interfere with signaling pathways that drive tumor growth in biliary tract neoplasms.
Zanidatamab is being developed by Zymeworks Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ZYME. Zymeworks is responsible for the clinical advancement of the drug, which is currently in Phase 3 testing for biliary tract neoplasms.
Zanidatamab is in Phase 3 clinical development. The ongoing trial is a randomized, active-controlled study, and the drug has not yet been approved by the FDA. It remains investigational for the treatment of biliary tract neoplasms.
Zanidatamab is being evaluated in the Phase 3 trial NCT05615818, titled Personalized Medicine for Advanced Biliary Cancer Patients. The trial is currently recruiting and has an estimated enrollment of 800 participants. It is being conducted in Belgium, France, and the United Kingdom.