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NCT06914128 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
A Phase 1 study of MTAP-deleted Solid Tumors, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 370
- Enrollment target
- 20
- Study locations
NCT06914128 is a Phase 1 study of MTAP-deleted Solid Tumors that is actively recruiting participants, run by Bayer. The registered enrollment target is 370 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT06914128, a Phase 1 study of MTAP-deleted Solid Tumors, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 370 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 591 total studies on file at ClinicalTrials.gov.
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.
NCT06914128 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, New South Wales, Colorado.
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.
What interventions are being tested in trial NCT06914128?
The interventions under investigation include: BAY 3713372 (DRUG).
Who is sponsoring clinical trial NCT06914128?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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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