RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing BAY 3713372 for MTAP-deleted Solid Tumors

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).

Official registry: https://clinicaltrials.gov/study/NCT06914128 · Bayer · enrollment listed as 450

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BAY 3713372. The registry lists allocation as randomized. The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors.

They plan to enroll about 450 people at 63 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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.

Interventions: BAY 3713372

Primary outcome (registry wording): Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Bayer Clinical Trials Contact

18888422937

clinical-trials-contact@bayer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

63 listed

UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital — Birmingham, Alabama (not_yet_recruiting)
City of Hope - Duarte Cancer Center — Duarte, California (not_yet_recruiting)
UCLA Health Bowyer Oncology Center — Los Angeles, California (not_yet_recruiting)
UCSF Helen Diller Medical Center at Parnassus Heights - Neurology — San Francisco, California (recruiting)
Stanford University Medical Center - Neurology — Stanford, California (not_yet_recruiting)
UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora, Colorado (not_yet_recruiting)
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's — Denver, Colorado (recruiting)
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona — Orlando, Florida (recruiting)
Massachusetts General Hospital - Neurology — Boston, Massachusetts (recruiting)
Dana-Farber Cancer Institute - Oncology Department — Boston, Massachusetts (not_yet_recruiting)
START | Midwest — Grand Rapids, Michigan (recruiting)
Icahn School of Medicine at Mount Sinai - Oncology — New York, New York (recruiting)

+ 46 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06914128 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06914128?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06914128?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary