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 tumours.
IRAS ID
1011570
Contact name
Rohan Pathmanathan
Contact email
Sponsor organisation
Bayer AG
Research summary
This study, titled “A study of PRMT5 inhibitor BAY 3713372 in participants with MTAP-deleted solid tumours” is testing a new drug called BAY 3713372, designed for patients with specific types of cancer known as solid tumours that have a deletion of the MTAP gene. This research is important because patients with these tumours often have no effective treatment options available.
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. The study will involve about 70 participants who have either MTAP deletion or another gene deletion called CDKN2A.
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.
This research is funded by Bayer, a pharmaceutical company, and will take place at multiple medical centers in the UK, EU, USA, Australia and Asia. It aims to provide new hope for patients with advanced cancers that currently lack effective treatments.REC name
London - Central Research Ethics Committee
REC reference
25/LO/0239
Date of REC Opinion
22 Apr 2025
REC opinion
Further Information Unfavourable Opinion