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JZP598

DRUG9 trials

Sponsors

Unicancer, Jazz Pharmaceuticals Ireland Limited, Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Conditions

Adult Patients with HER2-IHC3+ selected solid cancers (endometrialAdvanced Biliary Cancer (ABC)BTC - Biliary Tract CancerBreast cancer patients including those with locally advanced (unresectable) or metastatic HER2-positiveGastroesophageal AdenocarcinomaGastroesophageal Adenocarcinoma (GEA)HER2-positive breast cancerHR-positive breast cancer

Phase 2

Phase 2a Study of ZW25 in Combination with Palbociclib Plus Fulvestrant
CompletedCTIS2023-508135-30-00
Jazz Pharmaceuticals Ireland LimitedBreast cancer patients including those with locally advanced (unresectable) or metastatic HER2-positive, HR-positive breast cancer
Start: 2019-12-09End: 2025-06-30Target: 86Updated: 2025-03-25
AcSé HER2_Widening treatment options among adult patients with HER2-overexpressing or mutant solid cancers
RecruitingCTIS2025-522169-31-00
UnicancerAdult Patients with HER2-IHC3+ selected solid cancers (endometrial, colorectal, head & neck or sarcoma) or HER2 mutant non-small cell lung cancer.
Start: 2025-10-30Target: 105Updated: 2025-10-01
A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206)
Not yet recruitingCTIS2024-516551-41-00
Jazz Pharmaceuticals Ireland LimitedPatients with HER2-expressing solid tumors
Target: 50Updated: 2025-11-13
ZANGEA – Phase II Study of Zanidatamab in Combination with Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
RecruitingCTIS2025-522718-22-00
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbHGastroesophageal Adenocarcinoma
Start: 2025-12-16Target: 80Updated: 2026-01-16
A Phase 2, randomized, multicenter, open-label neoadjuvant study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer
Not yet recruitingCTIS2025-523204-68-00
Jazz Pharmaceuticals Ireland LimitedHER2-positive breast cancer
Target: 60Updated: 2026-01-14

Phase 3

SAFIR ABC10 : Molecular targeted maintenance therapy versus standard of care in advanced biliary cancer: an international, randomised, controlled, open-label, platform phase 3 trial
RecruitingCTIS2023-508100-38-00
UnicancerAdvanced Biliary Cancer (ABC)
Start: 2024-06-24Target: 450Updated: 2025-05-14
An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of-care therapy alone for advanced HER2 positive biliary tract cancer
RecruitingCTIS2023-508219-21-00
Jazz Pharmaceuticals Ireland LimitedBTC - Biliary Tract Cancer
Start: 2024-09-12Target: 93Updated: 2025-12-11
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
Active, not recruitingCTIS2023-510319-20-00
Jazz Pharmaceuticals Ireland LimitedGastroesophageal Adenocarcinoma (GEA)
Start: 2021-10-21Target: 251Updated: 2026-01-12
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment
RecruitingCTIS2023-508960-31-00
Jazz Pharmaceuticals Ireland LimitedMetastatic HER2-positive breast cancer
Start: 2024-12-03Target: 264Updated: 2025-09-04