First Study of BAY 3713372, a New PRMT5 Inhibitor, in Adults With MTAP-deleted Solid Tumors to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are evaluating BAY 3713372, a new drug designed to treat MTAP-deleted solid tumors by blocking a specific protein called PRMT5. This first-in-human study aims to understand how safe BAY 3713372 is, how the body processes it, and how well it works for people with these tumors. The study will monitor side effects, dosage limits, and the drugs levels in the blood over time. Participants will be grouped into eight different study cohorts. Initially, there will be a dose escalation phase where groups receive increasing doses of BAY 3713372 alone to find the safest and most effective dose. Afterward, a dose expansion phase will involve more participants receiving the drug alone or combined with other treatments. Participants may continue treatment as long as it remains beneficial without serious problems. Throughout the study, participants will visit the study site multiple times before and during treatment, with follow-up visits scheduled every nine weeks after treatment ends until cancer worsens or participation stops. Doctors will perform health checks, blood and urine tests, heart monitoring, and imaging scans like CT or MRI to assess tumor status. Tumor samples will be collected, and health updates will be gathered every three months for up to two years after the last dose or study end.

A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors