Therapy Detail

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Therapy Name BAY1895344
Synonyms
Therapy Description

BAY1895344 is a selective ATR inhibitor that inhibits proliferation of a variety of tumor cells (Proceedings of the AACR, Vol 58, Apr 2017, Abstract 983, PMID: 31836456).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
BAY1895344 BAY 1895344|BAY-1895344|Elimusertib ATR Inhibitor 16 BAY1895344 is a selective ATR inhibitor that inhibits proliferation of a variety of tumor cells (Proceedings of the AACR, Vol 58, Apr 2017, Abstract 983, PMID: 31836456).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATM negative Advanced Solid Tumor predicted - sensitive BAY1895344 Phase I Actionable In a Phase I trial, BAY1895344 treatment was tolerated and resulted in an objective response rate of 36.4% (4/11, all partial responses) and a disease control rate of 63.6% (7/11) in patients with advanced solid tumors harboring ATM inactivating mutations and/or ATM protein expression loss (PMID: 32988960; NCT03188965). 32988960
ATM negative collecting duct carcinoma predicted - sensitive BAY1895344 Case Reports/Case Series Actionable In a Phase I trial, BAY1895344 treatment resulted in a partial response with a 69% decrease in tumor size in a patient with renal collecting duct carcinoma harboring ATM protein loss, treatment was ongoing at 385 days (PMID: 32988960; NCT03188965). 32988960
ATM V1268fs appendix cancer predicted - sensitive BAY1895344 Case Reports/Case Series Actionable In a Phase I trial, BAY1895344 treatment resulted in a partial response with a 35% decrease in tumor size in a patient with appendix cancer harboring ATM T2333fs, treatment was ongoing at 472 days (PMID: 32988960; NCT03188965). 32988960
IDH1 R132H Advanced Solid Tumor sensitive BAY1895344 Preclinical - Cell culture Actionable In a preclinical study, treatment with BAY1895344 resulted in decreased survival in cell lines expressing IDH1 R132H in culture (PMID: 34027408). 34027408
ATM I2629fs ATM neg endometrial clear cell adenocarcinoma predicted - sensitive BAY1895344 Case Reports/Case Series Actionable In a Phase I trial, BAY1895344 treatment resulted in a partial response with a 53% decrease in tumor size in a patient with clear cell endometrial cancer harboring ATM I2629fs with ATM protein loss, treatment was ongoing at 433 days (PMID: 32988960; NCT03188965). 32988960
ATM T2333fs ATM neg Her2-receptor negative breast cancer predicted - sensitive BAY1895344 Case Reports/Case Series Actionable In a Phase I trial, BAY1895344 treatment resulted in a partial response with a 54% decrease in tumor size in a patient with heavily treated, hormone receptor-positive, ERBB2 (HER2)-negative breast cancer harboring ATM T2333fs and ATM protein loss, who remained on treatment for 349 days (PMID: 32988960; NCT03188965). 32988960
ATM inact mut Advanced Solid Tumor predicted - sensitive BAY1895344 Phase I Actionable In a Phase I trial, BAY1895344 treatment was tolerated and resulted in an objective response rate of 36.4% (4/11, all partial responses) and a disease control rate of 63.6% (7/11) in patients with advanced solid tumors harboring ATM inactivating mutations and/or ATM protein expression loss (PMID: 32988960; NCT03188965). 32988960

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05071209 Phase Ib/II BAY1895344 Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors Active, not recruiting USA | CAN 0
NCT03188965 Phase I BAY1895344 First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas Completed USA | GBR | CAN 4


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