BAY 3713372 / Suzhou Puhe Pharma, Bayer - LARVOL DELTA

A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors (clinicaltrials.gov) - P1/2 | N=450 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MTAP

A first-in-human, open-label, multi-part, phase I/II study of BAY 3713372, a novel 2nd generation PRMT5 inhibitor, in participants with MTAP-deleted solid tumors (ELCC 2026) - "The primary endpoint is the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints include dose-limiting toxicities and treatment-emergent or treatment-related adverse events, PK profile of monotherapy and combination regimens, and additional efficacy measures (duration of response, progression-free survival, and time to response assessed per RECIST 1.1)."

Clinical • First-in-human • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MTAP

A first-in-human study to learn how safe BAY 3713372 is and how it works in participants with MTAP-deleted solid tumors (clinicaltrialsregister.eu) - P1/2 | N=195 | Recruiting | Sponsor: Bayer AG

First-in-human • New P1/2 trial • Oncology • Solid Tumor • MTAP

A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors (clinicaltrials.gov) - P1/2 | N=370 | Recruiting | Sponsor: Bayer | Phase classification: P1 ➔ P1/2 | N=70 ➔ 370

Enrollment change • First-in-human • Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Bayer

New P1 trial • Oncology • Solid Tumor

Bayer and Puhe BioPharma enter into global license agreement for clinical phase I PRMT5 inhibitor (Bayer Press Release) - "Bayer and Suzhou Puhe BioPharma...announced that they have entered into a global license agreement for Puhe BioPharma’s oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors. Under the agreement, Bayer obtains an exclusive worldwide license to develop, manufacture and commercialize the MTA-cooperative PRMT5 inhibitor. Bayer has enrolled the first participant in a Phase I first-in-human dose escalation study investigating MTA-cooperative PRMT5 inhibitor under the development name BAY 3713372 for the treatment of MTAP-deleted solid tumors."

Licensing / partnership • Trial status