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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 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06/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-12-18"},{"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":"72e92596-829c-4510-aace-4fcdc49a7712","acronym":"YL202-INT-101-01","url":"https://clinicaltrials.gov/study/NCT05653752","created_at":"2022-12-16T14:58:14.992Z","updated_at":"2025-02-25T12:38:28.921Z","phase":"Phase 1","brief_title":"A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer","source_id_and_acronym":"NCT05653752 - YL202-INT-101-01","lead_sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","biomarkers":" EGFR • HER-2","pipe":" | ","alterations":" EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 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Ltd.","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 BNT326"],"overall_status":"Recruiting","enrollment":" Enrollment 200","initiation":"Initiation: 12/15/2023","start_date":" 12/15/2023","primary_txt":" Primary completion: 11/01/2026","primary_completion_date":" 11/01/2026","study_txt":" Completion: 11/01/2028","study_completion_date":" 11/01/2028","last_update_posted":"2024-11-15"},{"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":"3ab273df-ad84-463e-809d-9cbd385707ae","acronym":"","url":"https://clinicaltrials.gov/study/NCT05990803","created_at":"2023-08-14T14:10:30.823Z","updated_at":"2025-02-25T15:36:27.652Z","phase":"Phase 2","brief_title":"A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies","source_id_and_acronym":"NCT05990803","lead_sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","biomarkers":" HRD • BRCA","pipe":" | ","alterations":" HRD • BRCA mutation","tags":["HRD • BRCA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HRD • BRCA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)"],"overall_status":"Recruiting","enrollment":" Enrollment 130","initiation":"Initiation: 11/06/2023","start_date":" 11/06/2023","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":"2024-10-24"},{"id":"20c1edcd-7b1a-4a0e-a322-cf7af957ea0b","acronym":"","url":"https://clinicaltrials.gov/study/NCT06008054","created_at":"2023-08-23T15:11:10.298Z","updated_at":"2025-02-25T15:36:29.034Z","phase":"Phase 2","brief_title":"A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors","source_id_and_acronym":"NCT06008054","lead_sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 positive • HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)"],"overall_status":"Recruiting","enrollment":" Enrollment 376","initiation":"Initiation: 11/16/2023","start_date":" 11/16/2023","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-09-25"},{"id":"6478b2e2-568c-410e-9877-3d989cfbdd71","acronym":"","url":"https://clinicaltrials.gov/study/NCT05880706","created_at":"2023-05-30T14:05:24.607Z","updated_at":"2025-02-25T15:36:16.707Z","phase":"Phase 2","brief_title":"A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","source_id_and_acronym":"NCT05880706","lead_sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","biomarkers":" EGFR","pipe":" | ","alterations":" EGFR mutation • EGFR L858R • EGFR exon 19 deletion","tags":["EGFR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e EGFR mutation • EGFR L858R • EGFR exon 19 deletion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)"],"overall_status":"Recruiting","enrollment":" Enrollment 114","initiation":"Initiation: 07/19/2023","start_date":" 07/19/2023","primary_txt":" Primary completion: 07/01/2025","primary_completion_date":" 07/01/2025","study_txt":" Completion: 07/01/2025","study_completion_date":" 07/01/2025","last_update_posted":"2024-08-07"},{"id":"6bf2b896-e018-4a72-8241-0b41b1b66f40","acronym":"","url":"https://clinicaltrials.gov/study/NCT06118333","created_at":"2023-11-07T20:13:25.871Z","updated_at":"2025-02-25T15:36:37.862Z","phase":"Phase 3","brief_title":"A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","source_id_and_acronym":"NCT06118333","lead_sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","biomarkers":" PD-L1","pipe":"","alterations":" ","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)"],"overall_status":"Recruiting","enrollment":" Enrollment 368","initiation":"Initiation: 12/04/2023","start_date":" 12/04/2023","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-07-18"},{"id":"8ffc43aa-6147-4c99-a983-e627e958440f","acronym":"","url":"https://clinicaltrials.gov/study/NCT06042894","created_at":"2023-09-21T16:11:01.150Z","updated_at":"2025-02-25T15:36:32.414Z","phase":"Phase 2","brief_title":"A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer","source_id_and_acronym":"NCT06042894","lead_sponsor":"Sichuan Baili Pharmaceutical Co., Ltd.","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)"],"overall_status":"Recruiting","enrollment":" Enrollment 58","initiation":"Initiation: 12/12/2023","start_date":" 12/12/2023","primary_txt":" Primary completion: 12/01/2025","primary_completion_date":" 12/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2024-07-18"},{"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":"c96f1ef4-f1ba-44e1-a4de-73dd3b7750f4","acronym":"","url":"https://clinicaltrials.gov/study/NCT05511844","created_at":"2022-08-23T14:55:27.436Z","updated_at":"2024-07-02T16:35:12.094Z","phase":"Phase 1","brief_title":"Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors","source_id_and_acronym":"NCT05511844","lead_sponsor":"Orum Therapeutics USA, Inc.","biomarkers":" HER-2","pipe":"","alterations":" ","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ORM-5029"],"overall_status":"Recruiting","enrollment":" Enrollment 87","initiation":"Initiation: 10/03/2022","start_date":" 10/03/2022","primary_txt":" Primary completion: 04/01/2025","primary_completion_date":" 04/01/2025","study_txt":" Completion: 10/01/2025","study_completion_date":" 10/01/2025","last_update_posted":"2024-04-01"},{"id":"6ad1964d-0f6f-4cdd-938e-6b965c825842","acronym":"DB-1310-O-1001","url":"https://clinicaltrials.gov/study/NCT05785741","created_at":"2023-03-27T20:03:40.439Z","updated_at":"2024-07-02T16:35:18.020Z","phase":"Phase 1/2","brief_title":"A Study of DB-1310 in Advanced/Metastatic Solid Tumors","source_id_and_acronym":"NCT05785741 - DB-1310-O-1001","lead_sponsor":"DualityBio Inc.","biomarkers":" ERBB3","pipe":"","alterations":" ","tags":["ERBB3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e DB-1310"],"overall_status":"Recruiting","enrollment":" Enrollment 287","initiation":"Initiation: 04/10/2023","start_date":" 04/10/2023","primary_txt":" Primary completion: 08/31/2026","primary_completion_date":" 08/31/2026","study_txt":" Completion: 08/31/2026","study_completion_date":" 08/31/2026","last_update_posted":"2024-02-23"},{"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"}]