A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
NCT ID: NCT06914128
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
370 participants
INTERVENTIONAL
2025-03-21
2029-06-17
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Intervention Cohort 1)
For the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned.
BAY 3713372
Daily oral administration
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.
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 1)
Dose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors.
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 2)
Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC).
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 3)
Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 4)
Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 5)
Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC).
BAY 3713372
Daily oral administration
Dose Expansion (Intervention Cohort 6)
Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC.
BAY 3713372
Daily oral administration
Interventions
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BAY 3713372
Daily oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
Orlando, Florida, United States
START | Midwest
Grand Rapids, Michigan, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Dallas - Oncology Department
Irving, Texas, United States
START | San Antonio
San Antonio, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre
Concord, New South Wales, Australia
Calvary Mater Hospital Newcastle
Waratah, New South Wales, Australia
Northern Hospital
Epping, Victoria, Australia
Ghent University Hospital | Drug Research Unit Department
Ghent, , Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology
Liège, , Belgium
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, China
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
Brno, , Czechia
Fakultní Nemocnice Olomouc
Olomouc, , Czechia
Rigshospitalet - Kræftbehandling
Copenhagen, , Denmark
Odense University Hospital - Oncology Department
Odense C, , Denmark
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
Roma, , Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, , Italy
Shizuoka Cancer Center
Sunto, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Nederlands Kanker Instituut
Amsterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
National University Hospital Medical Centre
Singapore, , Singapore
National Cancer Center Singapore - Oncology Department
Singapore, , Singapore
Hospital Hm Nou Delfos - Oncologia
Barcelona, , Spain
Hospital Universitari Vall d'Hebron- Oncology Service
Barcelona, , Spain
Hospital San Pedro
Logroño, , Spain
The START Center for Cancer Care - Mardrid-Fundacion Jimenez Diaz (START Madrid-FJD)
Madrid, , Spain
Hospital Universitario Virgen De La Victoria - Oncology
Málaga, , Spain
NEXT Oncology- Next Madrid
Pozuelo de Alarcón, , Spain
Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)
Valencia, , Spain
Sahlgrenska Universitetssjukhuset - Klinisk prövningsenhet Fas I/FIH
Gothenburg, , Sweden
Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC
Stockholm, , Sweden
The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
London, Greater London, United Kingdom
The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team
Manchester, , United Kingdom
Countries
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Central Contacts
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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2025-520623-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
22931
Identifier Type: -
Identifier Source: org_study_id