Status:
RECRUITING
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
Lead Sponsor:
Bayer
Conditions:
MTAP-deleted Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-methyltransferas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 17 2029
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06914128
Start Date
March 21 2025
End Date
June 17 2029
Last Update
January 8 2026
Active Locations (44)
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1
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
Orlando, Florida, United States, 32827
3
START | Midwest
Grand Rapids, Michigan, United States, 49546
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203