A study to test the safety and effectiveness of BAY 3713372 alone and with drug combination in patients with MTAP-deleted solid tumors
- Participants:Adults
Rare diseases
Investigational molecules
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BAY 3713372 is an investigational medicine being developed by Bayer AG. It belongs to a class of drugs called PRMT5 inhibitors, which are targeted therapies designed to interfere with a specific protein that cancer cells rely on for growth.[2] The substance is described in trial records as a novel second-generation PRMT5 inhibitor, meaning it is a newer version of this type of drug with a design intended to be more selective.[2] BAY 3713372 has not received marketing authorisation and is available only within clinical trials.[1]
BAY 3713372 blocks the activity of an enzyme called PRMT5 (protein arginine methyltransferase 5). In cancer cells that have lost the MTAP gene, PRMT5 becomes a critical dependency, meaning the cells rely heavily on this enzyme to survive and multiply. By inhibiting PRMT5, BAY 3713372 aims to disrupt this survival mechanism and slow or stop tumor growth.[2] This approach is designed to spare healthy cells, which do not depend on PRMT5 in the same way, potentially leading to fewer side effects than traditional chemotherapy.
BAY 3713372 is taken by mouth as a tablet, once daily, in 21-day treatment cycles.[2] The trial also includes intravenous infusion arms for comparison, but the investigational drug itself is administered orally.[1]
One clinical trial of BAY 3713372 is registered in the sources reviewed. It is a Phase 1/2, first-in-human study with a planned enrollment of 450 participants, currently authorised but not yet recruiting.[1] The study has two main parts: a dose escalation phase to determine safety and the maximum tolerated dose, and a dose expansion phase to evaluate preliminary clinical activity in selected patient populations.[1]
Researchers are measuring several outcomes, including the number and severity of treatment-emergent adverse events (side effects that appear during treatment), dose-limiting toxicities, and how the drug moves through the body — its maximum concentration (Cmax) and area under the curve (AUC, or total drug exposure over time).[1] In the expansion phase, the objective response rate (ORR) will be assessed using standard criteria for measuring tumor shrinkage called RECIST v1.1.[1]
The study is designed for participants with MTAP-deleted or CDKN2A-deleted solid tumors, a group that often has few effective treatment options.[2]
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