A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors

NCT06914128 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 229312025-520623-24-00
• Study Type: interventional
• Target: 370
• Locations: 13 countries
• Sites: 60

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 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.

Conditions

MTAP-deleted Solid Tumors

Keywords

Solid Tumors; Non-small cell lung cancer; NSCLC; Pancreatic adenocarcinoma; PDAC

Outcome Measures

Primary Outcomes (9)

• 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 dictionary

  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)

  TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary

  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)

  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

  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)

  DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0

  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

  Number of participants with at least one DLT

  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

  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

  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)

  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 DLTs

  Number of participants with at least one DLT

  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)

Secondary Outcomes (13)

• Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR)

  Approximately 1.5 years

• Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR)

  Approximately 3 years

• Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS)

  Approximately 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)

  From the first administration of study intervention up to 30 days after the last dose of study intervention

Study Arms (8)

Dose Escalation (Intervention Cohort 1)

EXPERIMENTAL

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

Drug: BAY 3713372

Backfill cohorts in Intervention Cohort 1 (Dose Escalation)

EXPERIMENTAL

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

Dose Expansion (Intervention Cohort 1)

EXPERIMENTAL

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

Drug: BAY 3713372

Dose Expansion (Intervention Cohort 2)

EXPERIMENTAL

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

Drug: BAY 3713372

Dose Expansion (Intervention Cohort 3)

EXPERIMENTAL

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

Drug: BAY 3713372

Dose Expansion (Intervention Cohort 4)

EXPERIMENTAL

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

Drug: BAY 3713372

Dose Expansion (Intervention Cohort 5)

EXPERIMENTAL

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

Drug: BAY 3713372

Dose Expansion (Intervention Cohort 6)

EXPERIMENTAL

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

Drug: BAY 3713372

Interventions

BAY 3713372 DRUG

Daily oral administration

Backfill cohorts in Intervention Cohort 1 (Dose Escalation); Dose Escalation (Intervention Cohort 1); Dose Expansion (Intervention Cohort 1); Dose Expansion (Intervention Cohort 2); Dose Expansion (Intervention Cohort 3); Dose Expansion (Intervention Cohort 4); Dose Expansion (Intervention Cohort 5); Dose Expansion (Intervention Cohort 6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (60)

UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

City of Hope - Duarte Cancer Center

Duarte, California, 91010, United States

NOT YET RECRUITING

UCLA Health Bowyer Oncology Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights - Neurology

San Francisco, California, 94143, United States

NOT YET RECRUITING

Stanford University Medical Center - Neurology

Stanford, California, 94305, United States

NOT YET RECRUITING

UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

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

Denver, Colorado, 80218, United States

RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona

Orlando, Florida, 32827, United States

RECRUITING

Massachusetts General Hospital - Neurology

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute - Oncology Department

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

START | Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Icahn School of Medicine at Mount Sinai - Oncology

New York, New York, 10029, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center New York - Main Campus

New York, New York, 10065, United States

NOT YET RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

NEXT Dallas - Oncology Department

Irving, Texas, 75039, United States

RECRUITING

START | San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Froedtert Hospital - Clinical Cancer Center

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre

Concord, New South Wales, 2139, Australia

RECRUITING

Northern Hospital

Epping, New South Wales, 3076, Australia

SUSPENDED

Calvary Mater Hospital Newcastle - Oncology

Waratah, New South Wales, 2298, Australia

RECRUITING

UZ Leuven Gasthuisberg - Pneumology Department

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

Antwerp University Hospital | Oncology Department

Antwerp, 2650, Belgium

RECRUITING

Ghent University Hospital | Drug Research Unit Department

Ghent, 9000, Belgium

RECRUITING

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology

Liège, 4000, Belgium

RECRUITING

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing Municipality, 100142, China

RECRUITING

Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, Hubei, 430075, China

NOT YET RECRUITING

Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)

Brno, 602 00, Czechia

NOT YET RECRUITING

Fakultní nemocnice Olomouc - Onkologická klinika

Olomouc, 779 00, Czechia

NOT YET RECRUITING

Rigshospitalet - Kræftbehandling

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Odense University Hospital - Oncology Department

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

Aviano, 33081, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Milan, 20133, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

Roma, 00128, Italy

RECRUITING

I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione

Roma, 00144, Italy

NOT YET RECRUITING

Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

Rozzano, 20089, Italy

RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

NOT YET RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

NOT YET RECRUITING

Kindai University Hospital

Sakai, Osaka, 590-0197, Japan

NOT YET RECRUITING

Shizuoka Cancer Center

Sunto, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

Nederlands Kanker Instituut

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, South Holland, 3015 CE, Netherlands

NOT YET RECRUITING

Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

National University Hospital Medical Centre

Singapore, 119074, Singapore

RECRUITING

National Cancer Center Singapore - Oncology Department

Singapore, 168583, Singapore

RECRUITING

Icon Cancer Centre

Singapore, 217562, Singapore

NOT YET RECRUITING

Hospital San Pedro | Oncologia

Logroño, La Rioja, 26006, Spain

NOT YET RECRUITING

Clinica Universidad De Navarra | Pamplona | Oncologia

Pamplona, Madrid, 31008, Spain

NOT YET RECRUITING

NEXT - Hospital Universitario Quironsalud Madrid | Oncologia

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Hm Nou Delfos | Oncologia

Barcelona, 08023, Spain

RECRUITING

Hospital Universitari Vall D Hebron | Oncologia

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitario Fundacion Jimenez Diaz | Oncologia

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen De La Victoria | Oncologia

Málaga, 29010, Spain

RECRUITING

Hospital Clinico Universitario De Valencia | Oncologia

Valencia, 46010, Spain

NOT YET RECRUITING

Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC

Stockholm, Stockholm County, 171 76, Sweden

NOT YET RECRUITING

Sahlgrenska Universitetssjukhuset - Klinisk prövningsenhet Fas I/FIH

Gothenburg, Västra Götaland County, 413 46, Sweden

NOT YET RECRUITING

The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit

Sutton, Surrey, SM2 5PT, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team

Manchester, M20 5BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): June 17, 2029
• Study Completion (Estimated): June 17, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); JP (6); AU (4); IT (5); SG (3); SE (2); GB (2); CZ (2); CN (2); NL (3); ES (8); US (17); DK (2)