A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors
The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this firs
| Condition(s) | MTAP-deleted Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often |
| Who can participate | Inclusion Criteria: * Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent. * At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). * Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Bayer |
| Locations | Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Aurora, Colorado, United States (+54 more sites) |
| Start date | 2025-03-21 |
| NCT ID | NCT06914128 |
| Official listing | https://clinicaltrials.gov/study/NCT06914128 |