(22931) A first-in-human study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel 2nd generation PRMT5 inhibitor, in participants with MTAP-deleted solid tumors.

MTAP-deleted Solid Tumors

Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)., Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs)., Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)., Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs)., Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)., Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations., Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations., Dose Expansion (Master, Intervention Cohorts 1 – 6): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)., Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days).

Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)., Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1., Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1., Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR)., Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent adverse events (TEAEs)., Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent serious adverse events (TESAEs)., Dose Expansion (Master, Intervention Cohorts 1 – 6): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)., Dose Expansion (Master, Intervention Cohorts 1, 3, 4, and 6): Incidence of dose-limiting toxicities (DLTs)., Dose Expansion (Master, Intervention Cohorts 1 – 6): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1., Dose Expansion (Master, Intervention Cohorts 1 – 6): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1., Dose Expansion (Master, Intervention Cohorts 1 – 6): Time to response (TTR)., Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations., Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.

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