[{"id":"a3f2cdb8-5f51-4d49-bdd8-408b76b63c70","acronym":"ZANGEA","url":"https://clinicaltrials.gov/study/NCT07176312","created_at":"2025-09-20T07:08:39.876Z","updated_at":"2025-09-20T07:08:39.876Z","phase":"Phase 2","brief_title":"Phase II Study of Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients","source_id_and_acronym":"NCT07176312 - ZANGEA","lead_sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","biomarkers":" PD-L1","pipe":"","alterations":" ","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • Ziihera (zanidatamab-hrii)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 80","initiation":"Initiation: 10/01/2025","start_date":" 10/01/2025","primary_txt":" Primary completion: 03/01/2029","primary_completion_date":" 03/01/2029","study_txt":" Completion: 03/01/2029","study_completion_date":" 03/01/2029","last_update_posted":"2025-09-16"},{"id":"308e274e-e2f7-4972-a5fd-9ed7015b2fc2","acronym":"HERIZON-GEA-01","url":"https://clinicaltrials.gov/study/NCT05152147","created_at":"2021-12-09T18:00:29.644Z","updated_at":"2025-02-25T14:02:38.513Z","phase":"Phase 3","brief_title":"A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers","source_id_and_acronym":"NCT05152147 - HERIZON-GEA-01","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive • HER-2 expression","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HER-2 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • cisplatin • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)"],"overall_status":"Recruiting","enrollment":" Enrollment 918","initiation":"Initiation: 12/02/2021","start_date":" 12/02/2021","primary_txt":" Primary completion: 05/15/2025","primary_completion_date":" 05/15/2025","study_txt":" Completion: 05/15/2026","study_completion_date":" 05/15/2026","last_update_posted":"2025-02-19"},{"id":"142062db-36ca-4e14-9e8e-ac5f1782efb5","acronym":"","url":"https://clinicaltrials.gov/study/NCT04578444","created_at":"2021-01-18T21:51:12.506Z","updated_at":"2025-02-25T16:53:18.843Z","phase":"","brief_title":"An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer","source_id_and_acronym":"NCT04578444","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ziihera (zanidatamab-hrii)"],"overall_status":"Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2025-02-04"},{"id":"8cf55ab0-20f6-44cb-8bda-ecaebf4b0cba","acronym":"I-SPY 2","url":"https://clinicaltrials.gov/study/NCT01042379","created_at":"2021-01-17T17:27:23.313Z","updated_at":"2025-02-25T12:25:36.876Z","phase":"Phase 2","brief_title":"I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","source_id_and_acronym":"NCT01042379 - I-SPY 2","lead_sponsor":"QuantumLeap Healthcare Collaborative","biomarkers":" HER-2 • ER","pipe":" | ","alterations":" ER positive • ER negative","tags":["HER-2 • ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • ER negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • Zejula (niraparib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • Datroway (datopotamab deruxtecan-dlnk) • Ziihera (zanidatamab-hrii) • ganitumab (AMG 479) • amcenestrant (SAR439859) • anvatabart opadotin (JNJ-0683) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • vepdegestrant (ARV-471) • Cosela (trilaciclib) • Fablyn (lasofoxifene) • DAN-222 • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • rilvegostomig (AZD2936) • trebananib (AMG 386) • Kevzara (sarilumab) • Voyager-V1"],"overall_status":"Recruiting","enrollment":" Enrollment 5000","initiation":"Initiation: 03/01/2010","start_date":" 03/01/2010","primary_txt":" Primary completion: 12/01/2030","primary_completion_date":" 12/01/2030","study_txt":" Completion: 12/01/2031","study_completion_date":" 12/01/2031","last_update_posted":"2024-10-22"},{"id":"a3319e4d-f4d4-4df9-a108-3d23004da6fb","acronym":"","url":"https://clinicaltrials.gov/study/NCT06043427","created_at":"2023-09-21T15:10:26.808Z","updated_at":"2024-07-02T16:34:26.909Z","phase":"Phase 2","brief_title":"Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma","source_id_and_acronym":"NCT06043427","lead_sponsor":"Canadian Cancer Trials Group","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e paclitaxel • Cyramza (ramucirumab) • Ziihera (zanidatamab-hrii)"],"overall_status":"Recruiting","enrollment":" Enrollment 168","initiation":"Initiation: 04/16/2024","start_date":" 04/16/2024","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 06/30/2026","study_completion_date":" 06/30/2026","last_update_posted":"2024-06-12"},{"id":"285e0fae-6b50-4026-b6af-15e5137223d2","acronym":"ZWI-ZW25-201","url":"https://clinicaltrials.gov/study/NCT03929666","created_at":"2021-01-18T19:21:37.373Z","updated_at":"2024-07-02T16:34:37.769Z","phase":"Phase 2","brief_title":"A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer","source_id_and_acronym":"NCT03929666 - ZWI-ZW25-201","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" HER-2 • KRAS • BRAF • NRAS • RAS","pipe":" | ","alterations":" HER-2 amplification • HER-2 expression • KRAS wild-type • BRAF wild-type • NRAS wild-type","tags":["HER-2 • KRAS • BRAF • NRAS • RAS"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 expression • KRAS wild-type • BRAF wild-type • NRAS wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Avastin (bevacizumab) • cisplatin • gemcitabine • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Ziihera (zanidatamab-hrii)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 74","initiation":"Initiation: 08/29/2019","start_date":" 08/29/2019","primary_txt":" Primary completion: 11/28/2025","primary_completion_date":" 11/28/2025","study_txt":" Completion: 10/30/2026","study_completion_date":" 10/30/2026","last_update_posted":"2024-06-06"},{"id":"135a83dc-8c93-46d8-9a8a-d2365231d5e3","acronym":"HERIZON-BTC-01","url":"https://clinicaltrials.gov/study/NCT04466891","created_at":"2021-01-18T21:28:04.717Z","updated_at":"2024-07-02T16:35:00.002Z","phase":"Phase 2","brief_title":"A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers","source_id_and_acronym":"NCT04466891 - HERIZON-BTC-01","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 amplification","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ziihera (zanidatamab-hrii)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 87","initiation":"Initiation: 10/01/2020","start_date":" 10/01/2020","primary_txt":" Primary completion: 07/28/2023","primary_completion_date":" 07/28/2023","study_txt":" Completion: 10/31/2024","study_completion_date":" 10/31/2024","last_update_posted":"2024-05-30"},{"id":"8117a981-5eeb-4d92-af5c-165bae4f593a","acronym":"","url":"https://clinicaltrials.gov/study/NCT05035836","created_at":"2021-09-05T15:55:44.794Z","updated_at":"2024-07-02T16:35:08.196Z","phase":"Phase 2","brief_title":"A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)","source_id_and_acronym":"NCT05035836","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" HER-2","pipe":"","alterations":" ","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e tamoxifen • letrozole • Ziihera (zanidatamab-hrii)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 20","initiation":"Initiation: 11/16/2021","start_date":" 11/16/2021","primary_txt":" Primary completion: 12/29/2024","primary_completion_date":" 12/29/2024","study_txt":" Completion: 12/29/2024","study_completion_date":" 12/29/2024","last_update_posted":"2024-04-23"},{"id":"f2b35136-f790-410c-b54a-4f61af16101b","acronym":"ZWI-ZW25-101","url":"https://clinicaltrials.gov/study/NCT02892123","created_at":"2021-01-17T17:13:28.525Z","updated_at":"2024-07-02T16:35:08.789Z","phase":"Phase 1","brief_title":"Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers","source_id_and_acronym":"NCT02892123 - ZWI-ZW25-101","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" EGFR • HER-2 • KRAS • ALK • ROS1","pipe":" | ","alterations":" HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion","tags":["EGFR • HER-2 • KRAS • ALK • ROS1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e paclitaxel • capecitabine • Tukysa (tucatinib) • vinorelbine tartrate • Ziihera (zanidatamab-hrii)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 279","initiation":"Initiation: 09/30/2016","start_date":" 09/30/2016","primary_txt":" Primary completion: 06/01/2024","primary_completion_date":" 06/01/2024","study_txt":" Completion: 07/01/2024","study_completion_date":" 07/01/2024","last_update_posted":"2024-04-18"},{"id":"29296b3f-ec48-49ff-b4bb-867607bb9c9d","acronym":"ZW25-IST-2","url":"https://clinicaltrials.gov/study/NCT04513665","created_at":"2021-01-18T21:37:57.650Z","updated_at":"2024-07-02T16:35:15.131Z","phase":"Phase 2","brief_title":"ZW25 in Women With Endometrial Cancers","source_id_and_acronym":"NCT04513665 - ZW25-IST-2","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 overexpression • HER-2 amplification","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 overexpression • HER-2 amplification"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ziihera (zanidatamab-hrii)"],"overall_status":"Completed","enrollment":" Enrollment 17","initiation":"Initiation: 08/12/2020","start_date":" 08/12/2020","primary_txt":" Primary completion: 03/08/2024","primary_completion_date":" 03/08/2024","study_txt":" Completion: 03/08/2024","study_completion_date":" 03/08/2024","last_update_posted":"2024-03-12"},{"id":"183dce09-69e6-48a5-81e0-97d0021541d8","acronym":"ZWI-ZW25-202","url":"https://clinicaltrials.gov/study/NCT04224272","created_at":"2021-01-18T20:33:53.400Z","updated_at":"2024-07-02T16:35:26.906Z","phase":"Phase 2","brief_title":"A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer","source_id_and_acronym":"NCT04224272 - ZWI-ZW25-202","lead_sponsor":"Jazz Pharmaceuticals","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive • HR positive","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • fulvestrant • Ziihera (zanidatamab-hrii)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 51","initiation":"Initiation: 06/10/2020","start_date":" 06/10/2020","primary_txt":" Primary completion: 04/28/2023","primary_completion_date":" 04/28/2023","study_txt":" Completion: 10/26/2025","study_completion_date":" 10/26/2025","last_update_posted":"2023-12-06"}]