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New targeted drug takes aim at Hard-to-Treat cancers

NCT ID NCT06914128

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a new drug, BAY 3713372, for people with solid tumors that have a specific genetic deletion called MTAP. The drug is designed to kill cancer cells while sparing normal cells. The trial will first find a safe dose, then test how well it works in up to 450 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BAY 3713372 (a PRMT5 inhibitor)
What this could lead to
If successful, this could lead to a new targeted treatment option for people with MTAP-deleted solid tumors, potentially shrinking tumors or slowing their growth.
What could go wrong
This is an early first-in-human trial, so safety and effectiveness are not yet known. The drug may cause side effects or fail to work in many participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    63 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antwerp University Hospital | Oncology Department

    RECRUITING

    Antwerp, Antwerp, 2650, Belgium

  • Beijing Cancer Hospital - Oncology Department

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing chest hospital, Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Calvary Mater Hospital Newcastle - Oncology

    RECRUITING

    Waratah, New South Wales, 2298, Australia

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

    RECRUITING

    Liège, Liège, 4000, Belgium

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

    RECRUITING

    Aviano, 33081, Italy

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • City of Hope - Duarte Cancer Center

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad De Navarra | Pamplona | Oncologia

    RECRUITING

    Pamplona, 31008, Spain

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

    RECRUITING

    Concord, New South Wales, 2139, Australia

  • Dana-Farber Cancer Institute - Oncology Department

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Erasmus Medisch Centrum

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015 CE, Netherlands

  • Fakultní nemocnice Olomouc - Onkologická klinika

    RECRUITING

    Olomouc, Olomouc Region, 779 00, Czechia

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

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

    RECRUITING

    Roma, 00128, Italy

  • Froedtert Hospital - Clinical Cancer Center

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Ghent University Hospital | Drug Research Unit Department

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

  • Hospital Clinico Universitario De Valencia | Oncologia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital Hm Nou Delfos | Oncologia

    RECRUITING

    Barcelona, Barcelona, 08023, Spain

  • Hospital San Pedro | Oncologia

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Hospital Universitari Vall D Hebron | Oncologia

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Virgen De La Victoria | Oncologia

    RECRUITING

    Málaga, Málaga, 29010, Spain

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

    RECRUITING

    Rozzano, 20089, Italy

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

    NOT_YET_RECRUITING

    Roma, 00144, Italy

  • Icahn School of Medicine at Mount Sinai - Oncology

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Icon Cancer Centre

    RECRUITING

    Singapore, 217562, Singapore

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

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

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

    RECRUITING

    Stockholm, Stockholm County, 171 76, Sweden

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

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

    RECRUITING

    Brno, South Moravian, 602 00, Czechia

  • Massachusetts General Hospital - Neurology

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center New York - Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • NEXT - Hospital Universitario Quironsalud Madrid | Oncologia

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • NEXT Dallas - Oncology Department

    RECRUITING

    Irving, Texas, 75039, United States

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    NOT_YET_RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Cancer Center Singapore - Oncology Department

    RECRUITING

    Singapore, 168583, Singapore

  • National University Hospital Medical Centre

    RECRUITING

    Singapore, 119074, Singapore

  • Nederlands Kanker Instituut

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Northern Hospital

    NOT_YET_RECRUITING

    Epping, New South Wales, 3076, Australia

  • Odense University Hospital | Svendborg Sygehus - Oncology Department

    RECRUITING

    Odense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    RECRUITING

    Copenhagen, Capital Region / Region Hovedstaden, 2100, Denmark

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START | Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START | San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

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

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

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

    RECRUITING

    Orlando, Florida, 32827, United States

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

    RECRUITING

    Denver, Colorado, 80218, United States

  • Shizuoka Cancer Center

    RECRUITING

    Sunto, Shizuoka, 411-8777, Japan

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

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Stanford University Medical Center - Neurology

    NOT_YET_RECRUITING

    Stanford, California, 94305, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Christie Hospital | Experimental Cancer Medicine Team

    RECRUITING

    Manchester, Greater Manchester, M20 4BX, United Kingdom

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

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

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

    RECRUITING

    Wuhan, Hubei, 430075, China

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

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

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

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • UCLA Health Bowyer Oncology Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Helen Diller Medical Center at Parnassus Heights - Neurology

    NOT_YET_RECRUITING

    San Francisco, California, 94143, United States

  • UZ Leuven Gasthuisberg - Pneumology Department

    NOT_YET_RECRUITING

    Leuven, Flemish Brabant, 3000, Belgium

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

    RECRUITING

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

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Other studies related to the condition(s) this trial covers.