NCT06914128 · Bayer
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
BAY 3713372
Daily oral administration
Primary outcome measures
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From the first administration of study intervention up to 30 days after the last dose of study intervention
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs)
Time frame: From the first administration of study intervention up to 30 days after the last dose of study intervention
TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: From the first administration of study intervention up to 30 days after the last dose of study intervention
TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs)
Time frame: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0
Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs
Time frame: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Number of participants with at least one DLT
Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372
Time frame: From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372
Time frame: From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Dose Expansion (Master, Intervention Cohorts 1 - 6): Objective response rate (ORR)
Time frame: Approximately 1.5 years
Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs
Time frame: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Number of participants with at least one DLT
Intervention Cohort 7: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: From the first administration of study intervention up to 30 days after the last dose of study intervention
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Intervention Cohort 7: Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: From the first administration of study intervention up to 30 days after the last dose of study intervention
TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary
Intervention Cohort 7: Number of participants with DLTs
Time frame: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Number of participants with at least one DLT
Intervention Cohort 7: Brain and brain tumor PK concentration of BAY 3713372
Time frame: From first dose through day of surgery (approximately 7 ± 2 days)
Concentration of BAY 3713372 in enhancing and non-enhancing brain tumor tissue obtained at definitive surgery, with corresponding time-matched plasma concentrations and estimation of tumor-to-plasma exposure ratios
Intervention Cohort 7: Tumor tissue SDMA levels
Time frame: From first dose through day of surgery (approximately 7 ± 2 days)
Change in symmetric dimethylarginine (SDMA) levels in brain tumor tissue collected at definitive surgery following neoadjuvant BAY 3713372 treatment, as a pharmacodynamic marker of PRMT5 inhibition
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 i
Where
- Birmingham, Alabama
- Duarte, California
- Los Angeles, California
- San Francisco, California
- Stanford, California
- Aurora, Colorado
- Denver, Colorado
- Orlando, Florida
- Boston, Massachusetts
- Grand Rapids, Michigan
- New York, New York
- Nashville, Tennessee
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations