AzTrials
AzTrials

MTAP-deleted Solid TumorsPhase 1/2NCT06914128

A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors

A Phase 1/2 study testing BAY 3713372 in people with MTAP-deleted Solid Tumors, run by Bayer at 63 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MTAP-deleted Solid Tumors
What is being tested?
BAY 3713372
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
63 sitesin 13 countries
Study dates
21 Mar 2025to 18 Jun 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

18888422937

clinical-trials-contact@bayer.com

63 sites in 13 countries

United States17 sites, 17 recruiting

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

    Aurora, Colorado, 80045

    Not yet recruiting

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

    Birmingham, Alabama, 35233

    Not yet recruiting

  • Massachusetts General Hospital - Neurology

    Boston, Massachusetts, 02114

    Recruiting

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215

    Not yet recruiting

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

    Denver, Colorado, 80218

    Recruiting

  • City of Hope - Duarte Cancer Center

    Duarte, California, 91010

    Not yet recruiting

  • START | Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • NEXT Dallas - Oncology Department

    Irving, Texas, 75039

    Recruiting

  • UCLA Health Bowyer Oncology Center

    Los Angeles, California, 90095

    Not yet recruiting

  • Froedtert Hospital - Clinical Cancer Center

    Milwaukee, Wisconsin, 53226

    Not yet recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Icahn School of Medicine at Mount Sinai - Oncology

    New York, New York, 10029

    Recruiting

  • Memorial Sloan Kettering Cancer Center New York - Main Campus

    New York, New York, 10065

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona

    Orlando, Florida, 32827

    Recruiting

  • START | San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • UCSF Helen Diller Medical Center at Parnassus Heights - Neurology

    San Francisco, California, 94143

    Recruiting

  • Stanford University Medical Center - Neurology

    Stanford, California, 94305

    Not yet recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Hm Nou Delfos | Oncologia

    Barcelona, 08023

    Recruiting

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035

    Recruiting

  • Hospital San Pedro | Oncologia

    Logroño, La Rioja, 26006

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010

    Recruiting

  • Clinica Universidad De Navarra | Pamplona | Oncologia

    Pamplona, Chartered Community Of Navarre, 31008

    Recruiting

  • NEXT - Hospital Universitario Quironsalud Madrid | Oncologia

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital Clinico Universitario De Valencia | Oncologia

    Valencia, 46010

    Not yet recruiting

Other trials in Spain

Japan6 sites, 6 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Not yet recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

    Not yet recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Recruiting

  • Shizuoka Cancer Center

    Sunto, Shizuoka, 411-8777

    Recruiting

Other trials in Japan

China5 sites, 5 recruiting

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Beijing chest hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Not yet recruiting

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    Hangzhou, Zhejiang, 310016

    Not yet recruiting

  • Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Not yet recruiting

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

    Wuhan, Hubei, 430075

    Recruiting

Other trials in China

Italy5 sites, 5 recruiting

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

    Aviano, Friuli Venezia Giulia, 33081

    Recruiting

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

    Milan, Lombardy, 20133

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

    Rome, Lazio, 00128

    Recruiting

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

    Rome, Lazio, 00144

    Not yet recruiting

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

    Rozzano, Lombardy, 20089

    Recruiting

Other trials in Italy

Australia4 sites, 4 recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

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

    Concord, New South Wales, 2139

    Recruiting

  • Northern Hospital

    Epping, New South Wales, 3076

    Not yet recruiting

  • Calvary Mater Hospital Newcastle - Oncology

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Belgium4 sites, 4 recruiting

  • Antwerp University Hospital | Oncology Department

    Antwerp, Antwerp, 2650

    Recruiting

  • Ghent University Hospital | Drug Research Unit Department

    Ghent, East Flanders, 9000

    Recruiting

  • UZ Leuven Gasthuisberg - Pneumology Department

    Leuven, Flemish Brabant, 3000

    Recruiting

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

    Liège, 4000

    Recruiting

Other trials in Belgium

Netherlands3 sites, 3 recruiting

  • Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX

    Recruiting

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

    Groningen, 9713 GZ

    Not yet recruiting

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 CE

    Recruiting

Other trials in Netherlands

Singapore3 sites, 3 recruiting

  • National University Hospital Medical Centre

    Singapore, 119074

    Recruiting

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583

    Recruiting

  • Icon Cancer Centre

    Singapore, 217562

    Recruiting

Other trials in Singapore

Czechia2 sites, 2 recruiting

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

    Brno, South Moravian, 602 00

    Recruiting

  • Fakultní nemocnice Olomouc - Onkologická klinika

    Olomouc, Olomouc Region, 779 00

    Recruiting

Other trials in Czechia

Denmark2 sites, 2 recruiting

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    Copenhagen, Capital Region / Region Hovedstaden, 2100

    Recruiting

  • Odense University Hospital | Svendborg Sygehus - Oncology Department

    Odense, Region of Southern Denmark / Region Syddanmark, 5000

    Recruiting

Other trials in Denmark

Sweden2 sites, 2 recruiting

  • Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Klinisk prövningsenhet Fas I/FIH

    Gothenburg, Västra Götaland County, 413 46

    Not yet recruiting

  • Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC

    Stockholm, Stockholm County, 171 76

    Recruiting

Other trials in Sweden

United Kingdom2 sites, 2 recruiting

  • The Christie Hospital | Experimental Cancer Medicine Team

    Manchester, Greater Manchester, M20 4BX

    Recruiting

  • The Royal Marsden (Surrey) | Oak Foundation Drug Development Unit

    Sutton, Surrey, SM2 5PT

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, 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.

Read more

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.

Being tested
BAY 3713372
Keywords
Solid Tumors, Non-small cell lung cancer, NSCLC, Pancreatic adenocarcinoma, PDAC, Glioblastoma, GBM
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY 3713372Drug

    Daily oral administration

Study groups in NCT06914128
Study groupRoleWhat they receive
Dose Escalation (Intervention Cohort 1)ExperimentalFor the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned.
Receives: Drug: BAY 3713372
Backfill cohorts in Intervention Cohort 1 (Dose Escalation)ExperimentalBackfill 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.
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 1)ExperimentalDose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors.
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 2)ExperimentalDose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC).
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 3)ExperimentalDose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 4)ExperimentalDose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 5)ExperimentalDose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC).
Receives: Drug: BAY 3713372
Dose Expansion (Intervention Cohort 6)ExperimentalDose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC.
Receives: Drug: BAY 3713372
Window-of-opportunity trial in participants with MTAP-deleted GBM (Intervention Cohort 7)ExperimentalA surgical window-of-opportunity trial of BAY 3713372 alone in participants with MTAP-deleted glioblastoma (GBM).
Receives: Drug: BAY 3713372

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

    Measured: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

  5. Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs

    Number of participants with at least one DLT

    Measured: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

  6. Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372

    Measured: From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)

  7. Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372

    Measured: From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)

  8. 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)

    Measured: Approximately 1.5 years

  9. Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs

    Number of participants with at least one DLT

    Measured: 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)

  10. Intervention Cohort 7: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

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

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

  11. Intervention Cohort 7: Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

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

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

  12. Intervention Cohort 7: Number of participants with DLTs

    Number of participants with at least one DLT

    Measured: From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)

  13. Intervention Cohort 7: Brain and brain tumor PK concentration of BAY 3713372

    Concentration of BAY 3713372 in enhancing and non-enhancing brain tumor tissue obtained at definitive surgery, with corresponding time-matched plasma concentrations and estimation of tumor-to-plasma exposure ratios

    Measured: From first dose through day of surgery (approximately 7 ± 2 days)

  14. Intervention Cohort 7: Tumor tissue SDMA levels

    Change in symmetric dimethylarginine (SDMA) levels in brain tumor tissue collected at definitive surgery following neoadjuvant BAY 3713372 treatment, as a pharmacodynamic marker of PRMT5 inhibition

    Measured: From first dose through day of surgery (approximately 7 ± 2 days)

Secondary outcomes (19)

  1. 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)

    Measured: Approximately 1.5 years

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

    Determined by the investigator according to RECIST v1.1

    Measured: Approximately 3 years

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

    Determined by the investigator according to RECIST v1.1

    Measured: Approximately 3 years

  4. Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR)

    Measured: Approximately 1.5 years

  5. 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 dictionary

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

  6. 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 dictionary

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

  7. 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 dictionary

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

  8. 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.5.0

    Measured: 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)

  9. Dose Expansion (Master, Intervention Cohorts 1 - 6): Duration of response (DOR)

    Determined by the investigator according to RECIST v1.1

    Measured: Approximately 3 years

  10. Dose Expansion (Master, Intervention Cohorts 1 - 6): Progression-free survival (PFS)

    Determined by the investigator according to RECIST v1.1

    Measured: Approximately 3 years

  11. Dose Expansion (Master, Intervention Cohorts 1 - 6): Time to response (TTR)

    Measured: Approximately 1.5 years

  12. Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372

    Measured: From 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)

  13. Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372

    Measured: From 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)

  14. Dose Expansion (Part A of Intenvention Cohort 2): Time to CNS progression (CNS-TTP)

    Measured: Approximately 3 years

  15. Dose Expansion (Part B of Intervention Cohort 2): CNS-ORR for active brain metastases

    CNS-ORR: CNS objective response rate

    Measured: Approximately 1.5 years

  16. Dose Expansion (Part B of Intervention Cohort 2): CNS-DOR for active brain metastases

    CNS-DOR: Duration of CNS response

    Measured: Approximately 3 years

  17. Dose Expansion (Part B of Intervention Cohort 2): CNS-PFS for active brain metastases

    CNS-PFS: Survival without CNS progression

    Measured: Approximately 3 years

  18. Dose Expansion (Part B of Intervention Cohort 2): CNS-TTR for active brain metastases

    CNS-TTR: Time to CNS response

    Measured: Approximately 1.5 years

  19. Dose Expansion (Part B of Intervention Cohort 2): CNS-related disease control rate (CNS-DCR) in active brain metastases

    Measured: Approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start21 Mar 2025
  3. Primary completion18 Jun 2029 (estimated)
  4. Study completion18 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914128
Sponsor's protocol ID
22931
Other IDs
2025-520623-24-00, 2025
Status last verified
27 Oct 2026
First submitted
31 Mar 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BAY 3713372 in people with MTAP-deleted Solid Tumors, run by Bayer at 63 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Spain, Japan, China, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06914128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in