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Study of BAY 3713372 for MTAP-deleted Solid Tumors

This study is testing a new treatment called BAY 3713372 for people with MTAP-deleted solid tumors. BAY 3713372 is designed to block a protein called PRMT5, which may help kill cancer cells while leaving healthy cells alone. The main goals are to understand how safe BAY 3713372 is, how your body handles it, and if it shows any signs of working. Researchers will look at any side effects you might experience and their severity. You may be able to join if you are at least 18 years old and have a measurable tumor. This study aims to enroll 450 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a dose-escalation study, meaning different groups will receive different doses of BAY 3713372.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 30 days after their last dose of BAY 3713372.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06914128

A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bayer
~450 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:BAY 3713372

At a glance

Recruiting sites
35 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)
Measured over From the first administration of study intervention up to 30 days after the last dose of study intervention
+13 more outcomes measured

Conditions

MTAP-deleted Solid Tumors

Explore related trials

GlioblastomaLung Non-Small Cell CarcinomaPancreatic AdenocarcinomaSolid NeoplasmMTAP GenePRMT5 Gene

Where it's being run

60 sites across 38 states
Italy5
Spain5
California4
New South Wales4
Singapore3
Colorado2
Massachusetts2
New York2

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion

Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.
A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval \>450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.
Cardiac history comprising:
History of congestive heart failure Class \>II according to the New York Heart Association Functional Classification.
Myocardial infarction less than 6 months before the start of study intervention.
Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.
Unstable angina within 4 weeks before start of study intervention.

What this trial measures

  • Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)From the first administration of study intervention up to 30 days after the last dose of study intervention

    TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary

  • Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs)From the first administration of study intervention up to 30 days after the last dose of study intervention

    TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary

  • Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)From the first administration of study intervention up to 30 days after the last dose of study intervention

    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

  • Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs)From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

    DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0

  • Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTsFrom the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

    Number of participants with at least one DLT

  • Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
  • Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
  • Dose Expansion (Master, Intervention Cohorts 1 - 6): Objective response rate (ORR)Approximately 1.5 years

    Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

  • Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTsFrom the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)

    Number of participants with at least one DLT

  • Intervention Cohort 7: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)From the first administration of study intervention up to 30 days after the last dose of study intervention

    TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary

  • Intervention Cohort 7: Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)From the first administration of study intervention up to 30 days after the last dose of study intervention

    TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary

  • Intervention Cohort 7: Number of participants with DLTsFrom the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

    Number of participants with at least one DLT

  • Intervention Cohort 7: Brain and brain tumor PK concentration of BAY 3713372From first dose through day of surgery (approximately 7 ± 2 days)

    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

  • Intervention Cohort 7: Tumor tissue SDMA levelsFrom first dose through day of surgery (approximately 7 ± 2 days)

    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