Recruiting
Phase 1
Phase 2

BAY 3713372

Sponsor:

Bayer

Code:

NCT06914128

Conditions

MTAP-deleted Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BAY 3713372

Study Details

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-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 eight 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 twice before the treatment starts
  • multiple times when they start taking the treatment
  • once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason

During the study, the doctors and their study team will:

  • check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram
  • check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan
  • take tumor samples

The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.

Conditions

MTAP-deleted Solid Tumors

Study ID

NCT06914128

Start date

Mar 21, 2025

Status verified date

Jun, 2026

Completion date

Jun 17, 2029

Anticipated

Primary completion date

Jun 17, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 other 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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation (Intervention Cohort 1)

For the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned.

experimental: Backfill cohorts in Intervention Cohort 1 (Dose Escalation)

Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, pharmacokinetic, and pharmacodynamic data to facilitate the selection of the optimal doses for use in further development.

experimental: Dose Expansion (Intervention Cohort 1)

Dose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors.

experimental: Dose Expansion (Intervention Cohort 2)

Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC).

experimental: Dose Expansion (Intervention Cohort 3)

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.

experimental: Dose Expansion (Intervention Cohort 4)

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.

experimental: Dose Expansion (Intervention Cohort 5)

Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC).

experimental: Dose Expansion (Intervention Cohort 6)

Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC.

experimental: Window-of-opportunity trial in participants with MTAP-deleted GBM (Intervention Cohort 7)

A surgical window-of-opportunity trial of BAY 3713372 alone in participants with MTAP-deleted glioblastoma (GBM).

Interventions

BAY 3713372

Daily oral administration

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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) ]
  • 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 ]
  • 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) ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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) ]
  • Intervention Cohort 7: Tumor tissue SDMA levels [ Time Frame: From first dose through day of surgery (approximately 7 ± 2 days) ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

(+)1-888-84 22937clinical-trials-contact@bayer.com

Locations

Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's

Recruiting

Denver, Colorado, United States, 80218

Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona

Recruiting

Orlando, Florida, United States, 32827

START | Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

NEXT Dallas - Oncology Department

Recruiting

Irving, Texas, United States, 75039

START | San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Bayer

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Solid Tumors
  • Non-small cell lung cancer
  • NSCLC
  • Pancreatic adenocarcinoma
  • PDAC
  • Glioblastoma
  • GBM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bayer on 2026-06-26.