[{"id":"611fb533-b8fd-4219-b354-66257bca25a5","acronym":"","url":"https://clinicaltrials.gov/study/NCT04491942","created_at":"2021-01-18T21:34:47.482Z","updated_at":"2025-02-25T15:26:28.507Z","phase":"Phase 1","brief_title":"Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer","source_id_and_acronym":"NCT04491942","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cisplatin • gemcitabine • elimusertib (BAY 1895344) • liposomal gemcitabine (FF-10832)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 74","initiation":"Initiation: 08/25/2021","start_date":" 08/25/2021","primary_txt":" Primary completion: 06/30/2025","primary_completion_date":" 06/30/2025","study_txt":" Completion: 06/30/2025","study_completion_date":" 06/30/2025","last_update_posted":"2025-02-10"},{"id":"6365efdc-854e-4454-ba10-f28f09a5a11b","acronym":"PEPN2112","url":"https://clinicaltrials.gov/study/NCT05071209","created_at":"2021-10-08T11:53:44.641Z","updated_at":"2025-02-25T17:01:24.348Z","phase":"Phase 1/2","brief_title":"Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors","source_id_and_acronym":"NCT05071209 - PEPN2112","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" BRCA1 • BRCA2 • ATM • MSH2 • CDK12 • WT1 • ATRX • CHEK2 • RAD51 • FANCA • POLD1 • FOXO1 • XRCC2 • ATF1 • PAX3","pipe":" | ","alterations":" PAX3-FOXO1 fusion","tags":["BRCA1 • BRCA2 • ATM • MSH2 • CDK12 • WT1 • ATRX • CHEK2 • RAD51 • FANCA • POLD1 • FOXO1 • XRCC2 • ATF1 • PAX3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PAX3-FOXO1 fusion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e elimusertib (BAY 1895344)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 31","initiation":"Initiation: 12/22/2021","start_date":" 12/22/2021","primary_txt":" Primary completion: 09/30/2024","primary_completion_date":" 09/30/2024","study_txt":" Completion: 11/22/2025","study_completion_date":" 11/22/2025","last_update_posted":"2025-02-03"},{"id":"80611a75-8e50-4af0-8595-0b4412326e20","acronym":"","url":"https://clinicaltrials.gov/study/NCT04576091","created_at":"2021-01-18T21:50:45.107Z","updated_at":"2024-07-02T16:34:37.303Z","phase":"Phase 1","brief_title":"Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer","source_id_and_acronym":"NCT04576091","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" TMB • CD8 • CD4","pipe":" | ","alterations":" PD-L1 expression","tags":["TMB • CD8 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • cisplatin • elimusertib (BAY 1895344) • Pembroria (pembrolizumab biosimilar)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 37","initiation":"Initiation: 07/06/2022","start_date":" 07/06/2022","primary_txt":" Primary completion: 11/27/2024","primary_completion_date":" 11/27/2024","study_txt":" Completion: 11/27/2024","study_completion_date":" 11/27/2024","last_update_posted":"2024-06-07"},{"id":"8707fd4e-3c0c-4b6a-ae2e-951a25fe5fdd","acronym":"","url":"https://clinicaltrials.gov/study/NCT03188965","created_at":"2021-01-18T15:43:25.606Z","updated_at":"2025-02-25T17:09:45.567Z","phase":"Phase 2","brief_title":"First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas","source_id_and_acronym":"NCT03188965","lead_sponsor":"Bayer","biomarkers":" HER-2 • ER • PGR • ATM","pipe":" | ","alterations":" ER positive • HR positive • HER-2 negative • PGR positive","tags":["HER-2 • ER • PGR • ATM"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HR positive • HER-2 negative • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e elimusertib (BAY 1895344)"],"overall_status":"Completed","enrollment":" Enrollment 229","initiation":"Initiation: 07/06/2017","start_date":" 07/06/2017","primary_txt":" Primary completion: 12/02/2022","primary_completion_date":" 12/02/2022","study_txt":" Completion: 09/13/2023","study_completion_date":" 09/13/2023","last_update_posted":"2023-10-11"},{"id":"b779fc61-9ce2-46a0-bf31-8408e99ed716","acronym":"","url":"https://clinicaltrials.gov/study/NCT05010096","created_at":"2021-08-18T15:53:42.006Z","updated_at":"2024-07-02T16:36:09.743Z","phase":"Phase 1b","brief_title":"BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors","source_id_and_acronym":"NCT05010096","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" PIK3CA • BRCA1 • BRCA2 • PTEN • ATM • ARID1A • MSH2 • CDK12 • ATRX • CHEK2 • RAD51 • FANCA • RAD51B • BRIP1 • RAD51C • RAD51D • BARD1 • NBN • FANCF • FANCM • FANCD2 • FANCE • FANCC","pipe":" | ","alterations":" PIK3CA mutation • ATM mutation • PTEN mutation • ATM deletion • ATM expression","tags":["PIK3CA • BRCA1 • BRCA2 • PTEN • ATM • ARID1A • MSH2 • CDK12 • ATRX • CHEK2 • RAD51 • FANCA • RAD51B • BRIP1 • RAD51C • RAD51D • BARD1 • NBN • FANCF • FANCM • FANCD2 • FANCE • FANCC"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation • ATM mutation • PTEN mutation • ATM deletion • ATM expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Aliqopa (copanlisib) • elimusertib (BAY 1895344)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 03/22/2022","start_date":" 03/22/2022","primary_txt":" Primary completion: 03/22/2022","primary_completion_date":" 03/22/2022","study_txt":" Completion: 03/22/2022","study_completion_date":" 03/22/2022","last_update_posted":"2022-05-27"}]