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A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
NCT06914128 · View on ClinicalTrials.gov ↗
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 seven 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
Conditions Studied
Interventions
- DRUG BAY 3713372
Study Locations (20)
California
- City of Hope - Duarte Cancer Center — Duarte
- UCLA Health Bowyer Oncology Center — Los Angeles
- UCSF Helen Diller Medical Center at Parnassus Heights - Neurology — San Francisco
- Stanford University Medical Center - Neurology — Stanford
New South Wales
- Chris O'Brien Lifehouse — Camperdown
- Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre — Concord
- Northern Hospital — Epping
Colorado
- UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora
- Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's — Denver
Massachusetts
- Massachusetts General Hospital - Neurology — Boston
- Dana-Farber Cancer Institute - Oncology Department — Boston
New York
- Icahn School of Medicine at Mount Sinai - Oncology — New York
- Memorial Sloan Kettering Cancer Center New York - Main Campus — New York
Texas
- NEXT Dallas - Oncology Department — Irving
- START | San Antonio — San Antonio
Alabama
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital — Birmingham
Florida
- Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona — Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2025-03-21 |
| Est. Completion | 2029-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06914128
The ClinicalTrials.gov registry entry for NCT06914128 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with MTAP-deleted Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which BAY 3713372 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06914128 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New South Wales, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06914128 about?
NCT06914128 is a clinical study titled "A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With 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). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main o...
What is the current status of trial NCT06914128?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2025-03-21. Estimated completion is 2029-06-17.
What conditions does trial NCT06914128 study?
This clinical trial studies the following conditions: MTAP-deleted Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06914128?
The interventions under investigation include: BAY 3713372 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06914128?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06914128 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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