Name | Type | Description | Interventions |
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Dose escalation of BAY1895344 | Experimental | 2 dose levels of BAY1895344 are planned | |
Dose expansion cohort 1a of BAY1895344 | Experimental | Participants with advanced hormone-receptor-positive, Human epidermal growth factor receptor 2 (HER2)-negative Breast cancer (BC), known to be positive for ataxia-telangiectasia mutated (ATM) loss and/or ATM deleterious mutations who have not received prior treatment with immunotherapy. DDR+ participants with known MSI-H cannot be included. | |
Dose expansion cohort 1b of BAY1895344 | Experimental | Participants with advanced hormone-receptor-positive, HER2-negative BC, known to be DDR deficiency biomarker-positive (except ATM mutation) who have not received prior treatment with immunotherapy. DDR+ participants with known MSI-H cannot be included. | |
Dose expansion cohort 2a of BAY1895344 | Experimental | Participants with advanced Colorectal cancer (CRC) known to be positive for ATM loss and/or ATM deleterious mutations who have not received prior treatment with immunotherapy. DDR+ MSI-H CRC participants cannot be included. | |
Dose expansion cohort 2b of BAY1895344 | Experimental | Participants with advanced CRC, known to be DDR deficiency biomarker-positive (except ATM mutation) who have not received prior treatment with immunotherapy. DDR+ Microsatellite instability (MSI)-H CRC participants cannot be included. | |
Dose expansion cohort 3 of BAY1895344 | Experimental | Participants with advanced Gastric/Gastroesophageal junction (GEJ) cancer known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-Programmed cell death protein 1/ligand 1 (PD-1/L1) Monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or in combination with other therapies. | |
Dose expansion cohort 4 of BAY1895344 | Experimental | Participants with advanced Non-small cell lung cancer (NSCLC) known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or in combination with other therapies. | |
Dose expansion cohort 5 of BAY1895344 | Experimental | Participants with advanced pancreatic cancer, known to be DDR deficiency biomarker-positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. DDR+ participants with known MSI-H cannot be included. | |
Dose expansion cohort 6 of BAY1895344 | Experimental | Participants with advanced mCRPC, known to be DDR deficiency biomarker positive (incl. ATM mutation) and/or positive for ATM loss who have not received prior treatment with immunotherapy. DDR+ participants with known MSI-H cannot be included. | |