New targeted drug takes aim at Hard-to-Treat cancers
NCT ID NCT06914128
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
63 sites in 13 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Antwerp University Hospital | Oncology Department
RECRUITINGAntwerp, Antwerp, 2650, Belgium
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Beijing Cancer Hospital - Oncology Department
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Beijing chest hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 101149, China
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Calvary Mater Hospital Newcastle - Oncology
RECRUITINGWaratah, New South Wales, 2298, Australia
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Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology
RECRUITINGLiège, Liège, 4000, Belgium
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Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
RECRUITINGAviano, 33081, Italy
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Chris O'Brien Lifehouse
RECRUITINGCamperdown, New South Wales, 2050, Australia
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City of Hope - Duarte Cancer Center
NOT_YET_RECRUITINGDuarte, California, 91010, United States
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Clinica Universidad De Navarra | Pamplona | Oncologia
RECRUITINGPamplona, 31008, Spain
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Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre
RECRUITINGConcord, New South Wales, 2139, Australia
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Dana-Farber Cancer Institute - Oncology Department
RECRUITINGBoston, Massachusetts, 02215, United States
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Erasmus Medisch Centrum
NOT_YET_RECRUITINGRotterdam, South Holland, 3015 CE, Netherlands
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Fakultní nemocnice Olomouc - Onkologická klinika
RECRUITINGOlomouc, Olomouc Region, 779 00, Czechia
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Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
RECRUITINGRoma, 00128, Italy
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Froedtert Hospital - Clinical Cancer Center
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Ghent University Hospital | Drug Research Unit Department
RECRUITINGGhent, East Flanders, 9000, Belgium
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Hospital Clinico Universitario De Valencia | Oncologia
RECRUITINGValencia, Valencia, 46010, Spain
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Hospital Hm Nou Delfos | Oncologia
RECRUITINGBarcelona, Barcelona, 08023, Spain
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Hospital San Pedro | Oncologia
RECRUITINGLogroño, La Rioja, 26006, Spain
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Hospital Universitari Vall D Hebron | Oncologia
RECRUITINGBarcelona, Barcelona, 08035, Spain
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Hospital Universitario Fundacion Jimenez Diaz | Oncologia
RECRUITINGMadrid, Madrid, 28040, Spain
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Hospital Universitario Virgen De La Victoria | Oncologia
RECRUITINGMálaga, Málaga, 29010, Spain
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Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
RECRUITINGRozzano, 20089, Italy
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I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione
NOT_YET_RECRUITINGRoma, 00144, Italy
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Icahn School of Medicine at Mount Sinai - Oncology
NOT_YET_RECRUITINGNew York, New York, 10029, United States
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Icon Cancer Centre
RECRUITINGSingapore, 217562, Singapore
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Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITINGNanjing, Jiangsu, 210029, China
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Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC
RECRUITINGStockholm, Stockholm County, 171 76, Sweden
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Kindai University Hospital
RECRUITINGSakai, Osaka, 590-0197, Japan
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Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
RECRUITINGBrno, South Moravian, 602 00, Czechia
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Massachusetts General Hospital - Neurology
RECRUITINGBoston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center New York - Main Campus
RECRUITINGNew York, New York, 10065, United States
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NEXT - Hospital Universitario Quironsalud Madrid | Oncologia
RECRUITINGPozuelo de Alarcón, Madrid, 28223, Spain
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NEXT Dallas - Oncology Department
RECRUITINGIrving, Texas, 75039, United States
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Nagoya University Hospital
RECRUITINGNagoya, Aichi-ken, 466-8560, Japan
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National Cancer Center Hospital
RECRUITINGChuo-ku, Tokyo, 104-0045, Japan
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National Cancer Center Hospital East
NOT_YET_RECRUITINGKashiwa, Chiba, 277-8577, Japan
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National Cancer Center Singapore - Oncology Department
RECRUITINGSingapore, 168583, Singapore
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National University Hospital Medical Centre
RECRUITINGSingapore, 119074, Singapore
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Nederlands Kanker Instituut
RECRUITINGAmsterdam, North Holland, 1066 CX, Netherlands
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Northern Hospital
NOT_YET_RECRUITINGEpping, New South Wales, 3076, Australia
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Odense University Hospital | Svendborg Sygehus - Oncology Department
RECRUITINGOdense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark
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Rigshospitalet Copenhagen University Hospital | Oncology Department
RECRUITINGCopenhagen, Capital Region / Region Hovedstaden, 2100, Denmark
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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START | Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START | San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Klinisk prövningsenhet Fas I/FIH
RECRUITINGGothenburg, Västra Götaland County, 413 46, Sweden
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Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
RECRUITINGOrlando, Florida, 32827, United States
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Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
RECRUITINGDenver, Colorado, 80218, United States
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Shizuoka Cancer Center
RECRUITINGSunto, Shizuoka, 411-8777, Japan
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Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310016, China
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Stanford University Medical Center - Neurology
NOT_YET_RECRUITINGStanford, California, 94305, United States
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The Cancer Institute Hospital of JFCR
RECRUITINGKoto-ku, Tokyo, 135-8550, Japan
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The Christie Hospital | Experimental Cancer Medicine Team
RECRUITINGManchester, Greater Manchester, M20 4BX, United Kingdom
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The Royal Marsden Hospital (Sutton, Surrey) | Oak Foundation Drug Development Unit
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
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Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
RECRUITINGWuhan, Hubei, 430075, China
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UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITINGBirmingham, Alabama, 35233, United States
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UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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UCLA Health Bowyer Oncology Center
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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UCSF Helen Diller Medical Center at Parnassus Heights - Neurology
NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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UZ Leuven Gasthuisberg - Pneumology Department
NOT_YET_RECRUITINGLeuven, Flemish Brabant, 3000, Belgium
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Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center
RECRUITINGGroningen, Provincie Groningen, 9713 GZ, Netherlands
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