[{"id":"dc06b6ac-0a69-4fa1-bf0d-291d63c5c2bc","acronym":"HERTHENA-PanTumor01","url":"https://clinicaltrials.gov/study/NCT06172478","created_at":"2023-12-15T19:20:07.848Z","updated_at":"2025-02-25T13:41:58.738Z","phase":"Phase 2","brief_title":"A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","source_id_and_acronym":"NCT06172478 - HERTHENA-PanTumor01","lead_sponsor":"Daiichi Sankyo","biomarkers":" ERBB3","pipe":"","alterations":" ","tags":["ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 02/26/2024","start_date":" 02/26/2024","primary_txt":" Primary completion: 06/30/2025","primary_completion_date":" 06/30/2025","study_txt":" Completion: 04/30/2026","study_completion_date":" 04/30/2026","last_update_posted":"2025-02-21"},{"id":"d7b81edb-c5fd-48d0-bd93-16279271f44f","acronym":"ICARUS-BREAST01","url":"https://clinicaltrials.gov/study/NCT04965766","created_at":"2021-07-16T13:53:27.986Z","updated_at":"2025-02-25T15:44:32.072Z","phase":"Phase 2","brief_title":"Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer","source_id_and_acronym":"NCT04965766 - ICARUS-BREAST01","lead_sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","biomarkers":" HER-2","pipe":" | ","alterations":" HR positive • HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 99","initiation":"Initiation: 05/11/2021","start_date":" 05/11/2021","primary_txt":" Primary completion: 04/11/2025","primary_completion_date":" 04/11/2025","study_txt":" Completion: 04/11/2028","study_completion_date":" 04/11/2028","last_update_posted":"2025-02-10"},{"id":"2602482f-b076-444a-bfcf-8a98cc85e3b9","acronym":"","url":"https://clinicaltrials.gov/study/NCT06099639","created_at":"2023-10-25T19:14:02.621Z","updated_at":"2025-02-25T16:40:20.292Z","phase":"","brief_title":"Medical Access Program for Patritumab Deruxtecan","source_id_and_acronym":"NCT06099639","lead_sponsor":"Daiichi Sankyo","biomarkers":" ERBB3","pipe":" | ","alterations":" EGFR mutation • EGFR L858R • EGFR exon 19 deletion","tags":["ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e EGFR mutation • EGFR L858R • EGFR exon 19 deletion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Available","enrollment":"","initiation":"","start_date":"","primary_txt":"","primary_completion_date":"","study_txt":"","study_completion_date":"","last_update_posted":"2025-02-06"},{"id":"16881fd8-2992-4c6d-9d52-ffad01aae643","acronym":"HERTHENA-Lung01","url":"https://clinicaltrials.gov/study/NCT04619004","created_at":"2021-01-19T20:34:06.087Z","updated_at":"2025-02-25T16:10:47.804Z","phase":"Phase 2","brief_title":"HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer","source_id_and_acronym":"NCT04619004 - HERTHENA-Lung01","lead_sponsor":"Daiichi Sankyo","biomarkers":" ALK • ROS1","pipe":" | ","alterations":" EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion","tags":["ALK • ROS1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 277","initiation":"Initiation: 02/02/2021","start_date":" 02/02/2021","primary_txt":" Primary completion: 11/21/2022","primary_completion_date":" 11/21/2022","study_txt":" Completion: 01/30/2026","study_completion_date":" 01/30/2026","last_update_posted":"2024-12-04"},{"id":"cadb8f0d-9482-4575-b4e2-ae2b496d1ae5","acronym":"U31402-A-U102","url":"https://clinicaltrials.gov/study/NCT03260491","created_at":"2021-01-17T17:11:50.865Z","updated_at":"2025-02-25T16:06:47.472Z","phase":"Phase 1","brief_title":"U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer","source_id_and_acronym":"NCT03260491 - U31402-A-U102","lead_sponsor":"Daiichi Sankyo","biomarkers":" ALK • ROS1","pipe":" | ","alterations":" EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X","tags":["ALK • ROS1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Recruiting","enrollment":" Enrollment 309","initiation":"Initiation: 10/30/2017","start_date":" 10/30/2017","primary_txt":" Primary completion: 03/31/2026","primary_completion_date":" 03/31/2026","study_txt":" Completion: 12/31/2026","study_completion_date":" 12/31/2026","last_update_posted":"2024-11-22"},{"id":"d51630cc-a526-4c45-ba50-82d026376318","acronym":"U31402-A-J101","url":"https://clinicaltrials.gov/study/NCT02980341","created_at":"2021-01-17T17:33:44.191Z","updated_at":"2025-02-25T16:05:30.233Z","phase":"Phase 1/2","brief_title":"Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer","source_id_and_acronym":"NCT02980341 - U31402-A-J101","lead_sponsor":"Daiichi Sankyo Co., Ltd.","biomarkers":" HER-2 • ERBB3","pipe":" | ","alterations":" HR positive • HER-2 negative • HER-2 expression • ERBB3 positive","tags":["HER-2 • ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • HER-2 expression • ERBB3 positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Completed","enrollment":" Enrollment 182","initiation":"Initiation: 11/28/2016","start_date":" 11/28/2016","primary_txt":" Primary completion: 08/16/2021","primary_completion_date":" 08/16/2021","study_txt":" Completion: 09/07/2023","study_completion_date":" 09/07/2023","last_update_posted":"2024-10-30"},{"id":"ac428d9a-273b-4d56-88c0-0d08a880a183","acronym":"TUXEDO-3","url":"https://clinicaltrials.gov/study/NCT05865990","created_at":"2024-01-16T19:18:52.062Z","updated_at":"2024-07-02T16:35:03.380Z","phase":"Phase 2","brief_title":"HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease","source_id_and_acronym":"NCT05865990 - TUXEDO-3","lead_sponsor":"MedSIR","biomarkers":" HER-2 • ER • PGR • ERBB3 • TACSTD2","pipe":" | ","alterations":" HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M • ERBB3 expression • TROP2 expression • ER expression • PGR expression","tags":["HER-2 • ER • PGR • ERBB3 • TACSTD2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M • ERBB3 expression • TROP2 expression • ER expression • PGR expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Recruiting","enrollment":" Enrollment 60","initiation":"Initiation: 11/24/2023","start_date":" 11/24/2023","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 10/01/2026","study_completion_date":" 10/01/2026","last_update_posted":"2024-05-16"},{"id":"cbe988a0-8628-422d-8dff-97ed6ee0e4a4","acronym":"PARAMETer","url":"https://clinicaltrials.gov/study/NCT05620914","created_at":"2022-11-17T14:57:10.919Z","updated_at":"2024-07-02T16:35:19.319Z","phase":"Phase 1","brief_title":"A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases","source_id_and_acronym":"NCT05620914 - PARAMETer","lead_sponsor":"Mustafa Khasraw, MBChB, MD, FRCP, FRACP","biomarkers":" HER-2 • PGR • ERBB3","pipe":"","alterations":" ","tags":["HER-2 • PGR • ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 15","initiation":"Initiation: 04/01/2024","start_date":" 04/01/2024","primary_txt":" Primary completion: 01/01/2025","primary_completion_date":" 01/01/2025","study_txt":" Completion: 01/01/2027","study_completion_date":" 01/01/2027","last_update_posted":"2024-02-14"},{"id":"dcd3f303-075d-4fe3-9f59-a898ea289a77","acronym":"","url":"https://clinicaltrials.gov/study/NCT06222489","created_at":"2024-01-24T18:21:04.062Z","updated_at":"2024-07-02T16:35:21.346Z","phase":"Phase 2","brief_title":"Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT","source_id_and_acronym":"NCT06222489","lead_sponsor":"The Netherlands Cancer Institute","biomarkers":" ERBB3","pipe":"","alterations":" ","tags":["ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 16","initiation":"Initiation: 05/01/2024","start_date":" 05/01/2024","primary_txt":" Primary completion: 05/01/2027","primary_completion_date":" 05/01/2027","study_txt":" Completion: 05/01/2028","study_completion_date":" 05/01/2028","last_update_posted":"2024-02-01"},{"id":"1ecc2351-4f08-4e50-b996-5f839a75ff4c","acronym":"","url":"https://clinicaltrials.gov/study/NCT04699630","created_at":"2021-01-19T20:50:12.272Z","updated_at":"2024-07-02T16:35:22.414Z","phase":"Phase 2","brief_title":"A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer","source_id_and_acronym":"NCT04699630","lead_sponsor":"SCRI Development Innovations, LLC","biomarkers":" ER • ERBB3","pipe":" | ","alterations":" HER-2 positive • HER-2 negative • HER-2 expression • ERBB3 expression","tags":["ER • ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HER-2 negative • HER-2 expression • ERBB3 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Recruiting","enrollment":" Enrollment 121","initiation":"Initiation: 05/03/2021","start_date":" 05/03/2021","primary_txt":" Primary completion: 11/01/2025","primary_completion_date":" 11/01/2025","study_txt":" Completion: 11/01/2025","study_completion_date":" 11/01/2025","last_update_posted":"2024-01-24"},{"id":"5b010b67-89ab-4594-ae10-5083f9c9c6fe","acronym":"VALENTINE","url":"https://clinicaltrials.gov/study/NCT05569811","created_at":"2022-10-06T13:55:50.127Z","updated_at":"2024-07-02T16:35:36.270Z","phase":"Phase 2","brief_title":"NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial","source_id_and_acronym":"NCT05569811 - VALENTINE","lead_sponsor":"SOLTI Breast Cancer Research Group","biomarkers":" HER-2 • ER • PGR • ERBB3","pipe":" | ","alterations":" ER positive • HER-2 negative • ERBB3 expression • PGR positive","tags":["HER-2 • ER • PGR • ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • ERBB3 expression • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e paclitaxel • doxorubicin hydrochloride • cyclophosphamide • letrozole • epirubicin • patritumab deruxtecan (U3-1402)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 120","initiation":"Initiation: 11/25/2022","start_date":" 11/25/2022","primary_txt":" Primary completion: 03/31/2025","primary_completion_date":" 03/31/2025","study_txt":" Completion: 07/31/2030","study_completion_date":" 07/31/2030","last_update_posted":"2023-09-21"},{"id":"80825c94-3674-4a81-9512-e0927059f4a5","acronym":"SOLTI TOT-HER3","url":"https://clinicaltrials.gov/study/NCT04610528","created_at":"2021-01-19T20:32:21.175Z","updated_at":"2024-07-02T16:35:44.805Z","phase":"Phase 1","brief_title":"A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression","source_id_and_acronym":"NCT04610528 - SOLTI TOT-HER3","lead_sponsor":"SOLTI Breast Cancer Research Group","biomarkers":" HER-2 • ER • ERBB3","pipe":" | ","alterations":" ER positive • HER-2 negative • ERBB3 expression","tags":["HER-2 • ER • ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • ERBB3 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e patritumab deruxtecan (U3-1402)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 80","initiation":"Initiation: 12/22/2020","start_date":" 12/22/2020","primary_txt":" Primary completion: 01/30/2022","primary_completion_date":" 01/30/2022","study_txt":" Completion: 09/30/2023","study_completion_date":" 09/30/2023","last_update_posted":"2023-06-23"}]