Clinical trial • Phase I/II • Oncology
BAY 3713372 for MTAP-deleted solid tumors
Phase I/II trial of BAY 3713372 for MTAP-deleted solid tumors. open-label, none/not specified-controlled, adaptive. 175 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- MTAP-deleted solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-07-2025
- First CTIS Authorization Date
- 04-11-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial in Belgium, Czechia, Denmark and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, Dose-escalation design to determine MTD/MAD and/or recommended dose for expansion (RDE); followed by dose-expansion cohorts including combination with standard of care.
- Biomarker Stratified
- True, biomarker: Homozygous MTAP-deletion
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 175
Eligibility
Recruits 175 adults.
Inclusion criteria
- {"criterion_text":"- Participant age ≥ 18 years old with solid tumor and at least 1 evaluable lesion as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)"}
- {"criterion_text":"- Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory."}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
Exclusion criteria
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Unstable angina within 4 weeks before start of study intervention."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs).","definition_or_measurement_approach":"Count of participants experiencing treatment-emergent adverse events (TEAEs) during dose escalation."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs).","definition_or_measurement_approach":"Count of participants experiencing treatment-emergent serious adverse events (TESAEs) during dose escalation."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).","definition_or_measurement_approach":"Assessment and categorisation of severity for TEAEs and TESAEs (severity grading as per study safety reporting)."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs).","definition_or_measurement_approach":"Incidence (count) of DLTs observed during the dose-escalation period."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days).","definition_or_measurement_approach":"Number of participants experiencing DLTs from first dose through end of Cycle 1 (Cycle = 21 days)."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.","definition_or_measurement_approach":"Pharmacokinetic measurement of Cmax after single-dose and multiple-dose administrations for each dosing interval."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.","definition_or_measurement_approach":"Pharmacokinetic measurement of AUC after single-dose and multiple-dose administrations for each dosing interval."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).","definition_or_measurement_approach":"ORR determined by investigator assessment using RECIST v1.1 criteria."}
- {"endpoint_text":"- Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs from the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days).","definition_or_measurement_approach":"Number of participants experiencing DLTs from first dose through end of Cycle 1 (Cycle = 21 days) in specified expansion cohorts."}
Secondary endpoints
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR) as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).","definition_or_measurement_approach":"ORR determined by investigator using RECIST v1.1."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1.","definition_or_measurement_approach":"Duration of response per investigator assessment using RECIST v1.1."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1.","definition_or_measurement_approach":"PFS measured per investigator assessment using RECIST v1.1."}
- {"endpoint_text":"- Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR).","definition_or_measurement_approach":"Time from first dose to documented response."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent adverse events (TEAEs).","definition_or_measurement_approach":"Count of participants experiencing TEAEs in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Number of participants with treatment-emergent serious adverse events (TESAEs).","definition_or_measurement_approach":"Count of participants experiencing TESAEs in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).","definition_or_measurement_approach":"Assessment and categorisation of severity for TEAEs and TESAEs in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1, 3, 4, and 6): Incidence of dose-limiting toxicities (DLTs).","definition_or_measurement_approach":"Incidence (count) of DLTs in specified expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Duration of response (DOR) as determined by the Investigator according to RECIST v1.1.","definition_or_measurement_approach":"DOR measured per investigator assessment using RECIST v1.1 in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1.","definition_or_measurement_approach":"PFS measured per investigator assessment using RECIST v1.1 in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 6): Time to response (TTR).","definition_or_measurement_approach":"Time from first dose to documented response in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.","definition_or_measurement_approach":"Pharmacokinetic measurement of Cmax after single-dose and multiple-dose administrations in expansion cohorts."}
- {"endpoint_text":"- Dose Expansion (Master, Intervention Cohorts 1 – 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372 after single dose and multiple dose administrations.","definition_or_measurement_approach":"Pharmacokinetic measurement of AUC after single-dose and multiple-dose administrations in expansion cohorts."}
Recruitment
- Planned Sample Size
- 175
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent will be obtained from adult participants. Subject information and informed consent forms are provided for publication in country/language-specific documents (examples in registry: Czech (CS), Danish (DA), Italian (IT), Swedish (SV), English (EN), French (FR), Dutch (NL), Spanish (ES)). Dedicated ICF and supplementary documents (e.g., expecting parents forms, auxiliary ICFs, parent/guardian (PG) documents) are listed per country. Sponsor contact for trial ICF queries: clinical-trials-contact@bayer.com.
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 195
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 97
- Number Of Sites
- 4
- Number Of Participants
- 22
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Oncology
- Contact Person Name
- Hans Prenen
- Contact Person Email
- Hans.prenen@uza.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Drug Oncology
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- drug@uzgent.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Medical Oncology
- Contact Person Name
- Charles Pottier
- Contact Person Email
- charles.pottier@chuliege.be
- Site Name
- UZ Leuven
- Department Name
- Longziekten
- Contact Person Name
- Els Wauters
- Contact Person Email
- els.wauters@uzleuven.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 22
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Masarykuv onkologicky ustav
- Contact Person Name
- Peter Grell
- Contact Person Email
- peter.grell@mou.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Onkologicka klinika
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Odense University Hospital
- Department Name
- Oncology
- Contact Person Name
- Annette Kodahl
- Contact Person Email
- annette.kodahl@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Oncology
- Contact Person Name
- Martin Hoejgaard
- Contact Person Email
- martin.hoejgaard@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- direzione.generale@humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- direzione.scientifica@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact Person Name
- Matteo Duca
- Contact Person Email
- segreteria.oncologiamedica@istitutotumori.mi.it
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 26
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Verksamhet onkologi, Bla Straket 5, 413 46 Goteborg
- Contact Person Name
- Edvard Abel
- Contact Person Email
- gothia.forum@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- Fas 1-enheten Solna, CKS, Tema Cancer
- Contact Person Name
- Mark Zupancic
- Contact Person Email
- forumstockholmgotland.karolinska@regionstockholm.se
Spain
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 98
- Number Of Sites
- 8
- Number Of Participants
- 34
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Contact Person Name
- Desamparados Roda Perez
- Contact Person Email
- droda@incliva.es
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Irene Brana Garacia
- Contact Person Email
- ibrana@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- Javier Garcia Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
- Site Name
- Hospital San Pedro
- Department Name
- Oncology
- Contact Person Name
- Maria De Miguel Luken
- Contact Person Email
- maria.demiguel@startrioja.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Anna Vilalta Lacarra
- Contact Person Email
- avilaltal@unav.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 61
- Number Of Sites
- 3
- Number Of Participants
- 31
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Contact Person Name
- Derk Jan de Groot
- Contact Person Email
- researchcoordinator@onco.umcg.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Phase I Unit
- Contact Person Name
- Frans Opdam
- Contact Person Email
- CPM-CRU@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Sander Bins
- Contact Person Email
- ICV@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- 4g Clinical LLC
- Responsibilities
- code:3
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- code:4
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- code:14
Third parties
- {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG data collection and independant review","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Austria","full_name":"Biocrates Life Sciences AG","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BAY 3713372 Bayer
- Active Substance
- BAY 3713372
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- 1
- First In Human
- Yes
- Investigational Product Name
- BAY 3713372 Bayer
- Active Substance
- BAY 3713372
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- 1
- First In Human
- Yes
- Investigational Product Name
- -
- Active Substance
- -
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- 2
- Investigational Product Name
- -
- Active Substance
- -
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- 2
- Investigational Product Name
- -
- Active Substance
- -
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- 2
- Combination Treatment
- Yes
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