RecruitingPhase 1 / Phase 2NCT06914128
Official study title

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

Study summary

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-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. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will take part in one of the eight distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of 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. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBAY 3713372

The study team can explain what participation involves.

Who it may be forMTAP-deleted Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 10, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?63 U.S. locations

Locations may change over time.

Who runs it?Bayer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Bayer
Interventions being studied
Drug: BAY 3713372
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 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.
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB HospitalBirmingham, Alabama
  • City of Hope - Duarte Cancer CenterDuarte, California
  • UCLA Health Bowyer Oncology CenterLos Angeles, California
  • UCSF Helen Diller Medical Center at Parnassus Heights - NeurologySan Francisco, California
  • Stanford University Medical Center - NeurologyStanford, California
  • UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer CenterAurora, Colorado
  • Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke'sDenver, Colorado
  • Sarah Cannon Research Institute at Florida Cancer Specialists- Lake NonaOrlando, Florida
  • Massachusetts General Hospital - NeurologyBoston, Massachusetts
  • Dana-Farber Cancer Institute - Oncology DepartmentBoston, Massachusetts
  • START | MidwestGrand Rapids, Michigan
  • Icahn School of Medicine at Mount Sinai - OncologyNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 10, 2026. Always confirm current availability with the study team.

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