Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04466891 | A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers | PHASE2 | COMPLETED | 87 | — | — | Oct 1, 2020 | Jul 11, 2024 | Sep 15, 2025 | 67 | United States, Canada +7 |
Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions.
| Arm | Type | Description |
|---|---|---|
| ZW25 (Zanidatamab) Monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZW25 (Zanidatamab) | DRUG | Administered intravenously |
Inclusion Criteria: * Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC. * Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. * Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for...