RecruitingPhase I/IIEN originalOther cancers

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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. 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek minimum 18 lat
  • •Co najmniej jeden mierzalny guzek, który można obserwować w badaniach obrazowych
  • •Potwierdzona delecja genu MTAP wykazana w badaniu genetycznym
  • •Ogólny stan zdrowia pozwalający na aktywność codzienną (ECOG 0 lub 1)

✗ Disqualifies

  • •Inny nowotwór w ciągu ostatnich 2 lat (poza nowotworami skóry lub raka szyjki macicy)
  • •Poważne zaburzenia rytmu serca (przedłużony interval QT/QTc)
  • •Historia zawału serca w ciągu ostatnich 6 miesięcy
  • •Niestabilna choroba niedokrwienna serca w ciągu ostatnich 4 tygodni
  • •Historia poważnej niewydolności serca

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 10, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (63)

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

Birmingham, United States

City of Hope - Duarte Cancer Center

Duarte, United States

UCLA Health Bowyer Oncology Center

Los Angeles, United States

UCSF Helen Diller Medical Center at Parnassus Heights - Neurology

San Francisco, United States

Stanford University Medical Center - Neurology

Stanford, United States

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

Aurora, United States

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

Denver, United States

Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona

Orlando, United States

Massachusetts General Hospital - Neurology

Boston, United States

Dana-Farber Cancer Institute - Oncology Department

Boston, United States

START | Midwest

Grand Rapids, United States

Icahn School of Medicine at Mount Sinai - Oncology

New York, United States

Memorial Sloan Kettering Cancer Center New York - Main Campus

New York, United States

SCRI Oncology Partners

Nashville, United States

NEXT Dallas - Oncology Department

Irving, United States

START | San Antonio

San Antonio, United States

Froedtert Hospital - Clinical Cancer Center

Milwaukee, United States

Chris O'Brien Lifehouse

Camperdown, Australia

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

Concord, Australia

Northern Hospital

Epping, Australia

Calvary Mater Hospital Newcastle - Oncology

Waratah, Australia

Antwerp University Hospital | Oncology Department

Antwerp, Belgium

Ghent University Hospital | Drug Research Unit Department

Ghent, Belgium

UZ Leuven Gasthuisberg - Pneumology Department

Leuven, Belgium

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

Liège, Belgium

Beijing Cancer Hospital - Oncology Department

Beijing, China

Beijing chest hospital, Capital Medical University

Beijing, China

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

Wuhan, China

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

Nanjing, China

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

Hangzhou, China

Fakultní nemocnice Olomouc - Onkologická klinika

Olomouc, Czechia

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

Brno, Czechia

Rigshospitalet Copenhagen University Hospital | Oncology Department

Copenhagen, Denmark

Odense University Hospital | Svendborg Sygehus - Oncology Department

Odense, Denmark

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

Aviano, Italy

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

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I

Roma, Italy

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

Roma, Italy

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

Rozzano, Italy

Nagoya University Hospital

Nagoya, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kindai University Hospital

Sakai, Japan

Shizuoka Cancer Center

Sunto, Japan

National Cancer Center Hospital

Chuo-ku, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Japan

Nederlands Kanker Instituut

Amsterdam, Netherlands

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

Groningen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

National University Hospital Medical Centre

Singapore, Singapore

National Cancer Center Singapore - Oncology Department

Singapore, Singapore

Icon Cancer Centre

Singapore, Singapore

Hospital Hm Nou Delfos | Oncologia

Barcelona, Spain

Hospital Universitari Vall D Hebron | Oncologia

Barcelona, Spain

Hospital San Pedro | Oncologia

Logroño, Spain

Hospital Universitario Fundacion Jimenez Diaz | Oncologia

Madrid, Spain

NEXT - Hospital Universitario Quironsalud Madrid | Oncologia

Pozuelo de Alarcón, Spain

Hospital Universitario Virgen De La Victoria | Oncologia

Málaga, Spain

Hospital Clinico Universitario De Valencia | Oncologia

Valencia, Spain

Clinica Universidad De Navarra | Pamplona | Oncologia

Pamplona, Spain

Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC

Stockholm, Sweden

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

Gothenburg, Sweden

The Christie Hospital | Experimental Cancer Medicine Team

Manchester, United Kingdom

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

Sutton, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.

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