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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


2025-03-21


2029-06-17


2029-06-17


370

Study Overview

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 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 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.

N/A

  • MTAP-deleted Solid Tumors
  • DRUG: BAY 3713372
  • 22931
  • 2025-520623-24-00 (REGISTRY Identifier) (REGISTRY: CTIS (EU))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-03-31  

N/A  

2025-09-12  

2025-03-31  

N/A  

2025-09-18  

2025-04-06  

N/A  

2025-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Non Randomized


Interventional Model:
Sequential


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose Escalation (Intervention Cohort 1)

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

DRUG: BAY 3713372

  • Daily oral administration
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.

DRUG: BAY 3713372

  • Daily oral administration
EXPERIMENTAL: Dose Expansion (Intervention Cohort 1)

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

DRUG: BAY 3713372

  • Daily oral administration
EXPERIMENTAL: Dose Expansion (Intervention Cohort 2)

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

DRUG: BAY 3713372

  • Daily oral administration
EXPERIMENTAL: Dose Expansion (Intervention Cohort 3)

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

DRUG: BAY 3713372

  • Daily oral administration
EXPERIMENTAL: Dose Expansion (Intervention Cohort 4)

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

DRUG: BAY 3713372

  • Daily oral administration
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.

Primary Outcome MeasuresMeasure DescriptionTime Frame
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom 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)TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom 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)TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom 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)DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0From 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 DLTsNumber of participants with at least one DLTFrom 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 3713372From 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 3713372From 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)Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)Approximately 1.5 years
Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTsNumber of participants with at least one DLTFrom 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)
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR)Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)Approximately 1.5 years
Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR)Determined by the investigator according to RECIST v1.1Approximately 3 years
Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS)Determined by the investigator according to RECIST v1.1Approximately 3 years
Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR)Approximately 1.5 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Number of participants with treatment-emergent adverse events (TEAEs)TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1 - 6): Number of participants with treatment-emergent serious adverse events (TESAEs)TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1 - 6): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionaryFrom the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1, 3, 4, and 6): Incidence of dose-limiting toxicities (DLTs)DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0From 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)
Dose Expansion (Master, Intervention Cohorts 1 - 6): Duration of response (DOR)Determined by the investigator according to RECIST v1.1Approximately 3 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Progression-free survival (PFS)Determined by the investigator according to RECIST v1.1Approximately 3 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Time to response (TTR)Approximately 1.5 years
Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Bayer Clinical Trials Contact

Phone Number: (+)1-888-84 22937

Email: clinical-trials-contact@bayer.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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 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 after discussion with the sponsor.
  • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available