Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 3713372 · 1 trial · 1 indication
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0
Number of participants with at least one DLT
Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Number of participants with at least one DLT
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Number of participants with at least one DLT
Concentration of BAY 3713372 in enhancing and non-enhancing brain tumor tissue obtained at definitive surgery, with corresponding time-matched plasma concentrations and estimation of tumor-to-plasma exposure ratios
Change in symmetric dimethylarginine (SDMA) levels in brain tumor tissue collected at definitive surgery following neoadjuvant BAY 3713372 treatment, as a pharmacodynamic marker of PRMT5 inhibition
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Intervention Cohort 1) | EXPERIMENTAL | For the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned. |
| Backfill cohorts in Intervention Cohort 1 (Dose Escalation) | EXPERIMENTAL | Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, pharmacokinetic, and pharmacodynamic data to facilitate the selection of the optimal doses for use in further development. |
| Dose Expansion (Intervention Cohort 1) | EXPERIMENTAL | Dose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors. |
| Dose Expansion (Intervention Cohort 2) | EXPERIMENTAL | Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC). |
| Dose Expansion (Intervention Cohort 3) | EXPERIMENTAL | Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC. |
| Dose Expansion (Intervention Cohort 4) | EXPERIMENTAL | Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC. |
| Dose Expansion (Intervention Cohort 5) | EXPERIMENTAL | Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC). |
| Dose Expansion (Intervention Cohort 6) | EXPERIMENTAL | Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC. |
| Window-of-opportunity trial in participants with MTAP-deleted GBM (Intervention Cohort 7) | EXPERIMENTAL | A surgical window-of-opportunity trial of BAY 3713372 alone in participants with MTAP-deleted glioblastoma (GBM). |
| Name | Type | Description |
|---|---|---|
| BAY 3713372 | DRUG | Daily oral administration |
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 Cr...
BAY 3713372 is an investigational small molecule being studied for the treatment of MTAP-deleted solid tumors. It is not approved for any indication and remains in clinical development. The Phase 1 study enrolls adults with these biomarker-selected tumors across multiple countries.
BAY 3713372 is a PRMT5 inhibitor. It targets protein arginine methyltransferase 5 (PRMT5), an enzyme involved in cellular processes that support tumor growth. The trial is specifically designed for participants whose tumors have MTAP deletion, a biomarker that may sensitize cancers to PRMT5 inhibition.
BAY 3713372 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the ongoing Phase 1 clinical trial evaluating the compound in MTAP-deleted solid tumors.
BAY 3713372 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority. The single ongoing trial is currently recruiting participants.
BAY 3713372 is being evaluated in one active clinical trial, NCT06914128, titled A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors. The Phase 1 study is recruiting and plans to enroll approximately 450 participants across the United States, Australia, Belgium, China, Czechia, Denmark, Italy, Japan, Netherlands, Singapore, Spain, Sweden, and the United Kingdom.