A study of PRMT5 inhibitor BAY 3713372 in participants with MTAP-deleted solid tumors

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  1012416

• Contact name

  Rohan Pathmanathan

• Contact email

  rohan.pathmanathan@bayer.com

• Sponsor organisation

  Bayer AG

• Research summary

  The study treatment, BAY 3713372, is under development to treat MTAP-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.
  People with MTAP-deleted tumors often have limited treatment options, and their cancer may not respond well to standard therapies. This is the first study of BAY 3713372 in humans.
  Participants will take part in one of the 6 different groups of the study. The study will start with a dose escalation phase where participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase.

  The main goals of this study are to determine if BAY 3713372 is safe, to find the best dose, and to see if it shows any early signs of effectiveness against these tumours. In addition, to also understand how well BAY 3713372 works both alone and in combination with other treatments.
  Participants in the study will first undergo a screening period to assess their eligibility, which includes signing an informed consent form and various medical evaluations. Once enrolled, they will take the drug BAY 3713372 as a pill once a day for 21-day cycles, with regular monitoring of participant’s safety, side effects and overall health. After treatment, participants will have an end-of- treatment visit, followed by active follow-up assessments to monitor their health and tumor status, and long-term follow-up every three months for up to 24 months to check on their survival and overall well-being.

• REC name

  HSC REC A

• REC reference

  25/NI/0116

• Date of REC Opinion

  3 Oct 2025

• REC opinion

  Further Information Favourable Opinion