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NCT04578444
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
trial testing Zanidatamab in HER2-Positive Advanced Biliary Tract Cancer. No longer available.
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 17 locations across France, Italy, United Kingdom, United States, Spain |
Drugs / interventions tested
- Zanidatamab (ZANIDATAMAB) — full drug profile →
Conditions studied
- HER2-Positive Advanced Biliary Tract Cancer — all drugs for HER2-Positive Advanced Biliary Tract Cancer →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with HER2-Positive Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging Targeted Therapies for HER2-Positive Breast Cancer.
Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987 -
Revolutionizing cancer immunotherapy: unleashing the potential of bispecific antibodies for targeted treatment.
Guo X, Wu Y, Xue Y, Xie N, et al · · 2023 · cited 15× · PMID 38106416 · DOI 10.3389/fimmu.2023.1291836
Verify or expand the search:
- PubMed search for NCT04578444
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Zanidatamab
Trials testing the same drug.
- NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
- NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I · Phase 2 · recruiting
- NCT07243938 — Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET) · Phase 2 · not yet recruiting
- NCT07192068 — Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration · Phase 2 · recruiting
Other Jazz Pharmaceuticals trials
Trials by the same sponsor.
- NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
- NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
- NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04578444 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
- Last refreshed: 25 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04578444.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing