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NCT04466891 · ClinicalTrials.gov registry record · Phase 2
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT04466891: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT04466891 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04466891, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study Summary
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
Primary Outcome
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.
Interventions
- DRUG ZW25 (Zanidatamab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2024-07-11 |
| Phase | Phase 2 |
What the finished NCT04466891 record still lists
NCT04466891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which ZW25 (Zanidatamab) is the first listed.
NCT04466891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04466891 about?
NCT04466891 is a clinical study titled "A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers". This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcin...
What is the current status of trial NCT04466891?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2020-10-01. Estimated completion is 2024-07-11.
What interventions are being tested in trial NCT04466891?
The interventions under investigation include: ZW25 (Zanidatamab) (DRUG).
Who is sponsoring clinical trial NCT04466891?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04466891's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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