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Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

StatusRecruiting
PhasePhase 3
Started2024-07-19
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
Study Status, Contacts/Locations v27
Study sitesdetails revised at 113 of 185 sites
2026-07-13
Study Status, IPDSharing v26
Re-verified, no change to tracked fields
2026-05-07
Study Status, Contacts/Locations v25
Study sites184→185
2026-03-23
Study Status, Contacts/Locations v24
Study sites183→184
2026-02-23
3 amendments v21-v23
3 re-verifications since 2025-12-16, no change to tracked fields
Show 20 earlier versions
2025-11-20
Study Status, Contacts/Locations v20
Study sitesdetails revised at 16 of 183 sites
2025-10-20
Study Status, Contacts/Locations v19
Study sites178→183
2025-09-15
Study Status, Contacts/Locations v18
Study sites175→178
2025-08-19
Study Status, Contacts/Locations v17
Study sites174→175
2025-07-29
Study Status, Contacts/Locations v16
Study sites169→174
2025-06-20
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 169 sites
2025-06-20
Study Status, Contacts/Locations v14
Study sites163→169
2025-05-08
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v13
Primary completion date2028-07-01→2028-12-01
Completion date2029-11-01→2030-04-01
Study sites153→163
Eligibility criteria+33 characters
[...] iocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).. Locally advanced unresectable or metastatic BTC and not eli [...] erapies. Received no more than 2 cycles of systemic therapy withwhich gemcitabineis limited to Cisplatin and aGemcitabine platinum agent(CisGem) with or without a PD-1/L1 inhibitor (physician's choice of [...] or, could impact safety or compliance with study procedures. Use of phenytoin
2025-03-21
Study Status, Contacts/Locations v12
Study sites146→153
2025-02-25
Study Status, Conditions v11
Re-verified, no change to tracked fields
2025-02-25
Study Status, Contacts/Locations v10
Study sites130→146
2025-01-21
Study Status, Contacts/Locations v9
Study sites104→130
2024-12-04
Study Status, Contacts/Locations v8
Study sites71→104
2024-11-11
Study Status, Contacts/Locations v7
Study sites43→71
2024-09-20
Study Status, Contacts/Locations v6
Study sites21→43
2024-08-27
Study Status, Contacts/Locations v5
Study sites12→21
2024-07-30
Study Status, Contacts/Locations v4
Start dateestimated 2024-06-30→confirmed 2024-07-19
Study sites7→12
2024-06-05
Study Status, Contacts/Locations v3
Study sites6→7
2024-05-31
Study Status, Contacts/Locations v2
Start date2024-04-30→2024-06-30
Study sitesdetails revised at 1 of 6 sites
2024-04-04
Study Status, Contacts/Locations v1
Start date2024-03-01→2024-04-30
Study sites2→6
2024-02-21
Original filing
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
Trial Details
NCT Number NCT06282575
Lead Sponsor Jazz Pharmaceuticals
Conditions Biliary Tract Cancer
Enrollment 286 participants
Start Date 2024-07-19
Primary Completion 2028-12-01 (estimated)
Study Completion 2030-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-14