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Testing the safety of BAY 3713372 in patients with specific solid tumors

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 Tumors.

Phase1; Phase2 Interventional Bayer · NCT06914128

This study is testing a new drug called BAY 3713372 to see if it's safe for people with specific solid tumors that have a certain genetic change and who have already tried other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment370 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT06914128 on ClinicalTrials.gov

What this trial studies

This first-in-human study evaluates the safety and dosage of BAY 3713372, a treatment aimed at patients with MTAP-deleted solid tumors. The study will assess the occurrence and severity of adverse events and dose-limiting toxicities in participants receiving varying doses of the drug. By identifying a safe dosage, the research aims to pave the way for future studies targeting different cancer types with similar genetic deletions. Participants must have previously exhausted standard treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with solid tumors that have a confirmed homozygous MTAP deletion.

Not a fit: Patients with other active cancers or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with MTAP-deleted solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting specific genetic alterations in cancer have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 Criteria:

* Previous additional cancer else 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.

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MTAP-deleted Solid TumorsSolid TumorsNon-small cell lung cancerNSCLCPancreatic adenocarcinomaPDAC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.