Actively Recruiting
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
Led by Bayer · Updated on 2026-04-17
370
Participants Needed
60
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 seven 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.
CONDITIONS
Official Title
A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older or legal age of consent at enrollment
- Have at least one measurable tumor lesion according to RECIST 1.1 criteria
- Confirmed homozygous MTAP deletion by molecular testing from a certified lab
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Diagnosis of another cancer within the past 2 years except for certain skin, cervical, bladder, or prostate cancers considered cured
- Prolonged QT/QTc interval greater than 450 ms at screening, unless approved by investigator
- History of congestive heart failure Class greater than II
- Heart attack within 6 months before study start
- Serious heart rhythm problems requiring treatment or important ECG abnormalities (except well-controlled atrial fibrillation)
- Unstable angina within 4 weeks before study start treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
City of Hope - Duarte Cancer Center
Duarte, California, United States, 91010
Not Yet Recruiting
3
UCLA Health Bowyer Oncology Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
UCSF Helen Diller Medical Center at Parnassus Heights - Neurology
San Francisco, California, United States, 94143
Not Yet Recruiting
5
Stanford University Medical Center - Neurology
Stanford, California, United States, 94305
Not Yet Recruiting
6
UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Not Yet Recruiting
7
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, Colorado, United States, 80218
Actively Recruiting
8
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
9
Massachusetts General Hospital - Neurology
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
10
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
11
START | Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
12
Icahn School of Medicine at Mount Sinai - Oncology
New York, New York, United States, 10029
Not Yet Recruiting
13
Memorial Sloan Kettering Cancer Center New York - Main Campus
New York, New York, United States, 10065
Not Yet Recruiting
14
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
NEXT Dallas - Oncology Department
Irving, Texas, United States, 75039
Actively Recruiting
16
START | San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
17
Froedtert Hospital - Clinical Cancer Center
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
18
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
19
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre
Concord, New South Wales, Australia, 2139
Actively Recruiting
20
Northern Hospital
Epping, New South Wales, Australia, 3076
Suspended
21
Calvary Mater Hospital Newcastle - Oncology
Waratah, New South Wales, Australia, 2298
Actively Recruiting
22
UZ Leuven Gasthuisberg - Pneumology Department
Leuven, Vlaams-Brabant, Belgium, 3000
Not Yet Recruiting
23
Antwerp University Hospital | Oncology Department
Antwerp, Belgium, 2650
Actively Recruiting
24
Ghent University Hospital | Drug Research Unit Department
Ghent, Belgium, 9000
Actively Recruiting
25
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology
Liège, Belgium, 4000
Actively Recruiting
26
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
27
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, China, 430075
Not Yet Recruiting
28
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
Brno, Czechia, 602 00
Not Yet Recruiting
29
Fakultní nemocnice Olomouc - Onkologická klinika
Olomouc, Czechia, 779 00
Not Yet Recruiting
30
Rigshospitalet - Kræftbehandling
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
31
Odense University Hospital - Oncology Department
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
32
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
Aviano, Italy, 33081
Not Yet Recruiting
33
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Italy, 20133
Not Yet Recruiting
34
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
Roma, Italy, 00128
Actively Recruiting
35
I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione
Roma, Italy, 00144
Not Yet Recruiting
36
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Italy, 20089
Actively Recruiting
37
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Not Yet Recruiting
38
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Not Yet Recruiting
39
Kindai University Hospital
Sakai, Osaka, Japan, 590-0197
Not Yet Recruiting
40
Shizuoka Cancer Center
Sunto, Shizuoka, Japan, 411-8777
Actively Recruiting
41
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
42
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
43
Nederlands Kanker Instituut
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
44
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands, 3015 CE
Not Yet Recruiting
45
Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
46
National University Hospital Medical Centre
Singapore, Singapore, 119074
Actively Recruiting
47
National Cancer Center Singapore - Oncology Department
Singapore, Singapore, 168583
Actively Recruiting
48
Icon Cancer Centre
Singapore, Singapore, 217562
Not Yet Recruiting
49
Hospital San Pedro | Oncologia
Logroño, La Rioja, Spain, 26006
Not Yet Recruiting
50
Clinica Universidad De Navarra | Pamplona | Oncologia
Pamplona, Madrid, Spain, 31008
Not Yet Recruiting
51
NEXT - Hospital Universitario Quironsalud Madrid | Oncologia
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
52
Hospital Hm Nou Delfos | Oncologia
Barcelona, Spain, 08023
Actively Recruiting
53
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain, 08035
Not Yet Recruiting
54
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
Madrid, Spain, 28040
Actively Recruiting
55
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, Spain, 29010
Actively Recruiting
56
Hospital Clinico Universitario De Valencia | Oncologia
Valencia, Spain, 46010
Not Yet Recruiting
57
Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC
Stockholm, Stockholm County, Sweden, 171 76
Not Yet Recruiting
58
Sahlgrenska Universitetssjukhuset - Klinisk prövningsenhet Fas I/FIH
Gothenburg, Västra Götaland County, Sweden, 413 46
Not Yet Recruiting
59
The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
Sutton, Surrey, United Kingdom, SM2 5PT
Not Yet Recruiting
60
The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team
Manchester, United Kingdom, M20 5BX
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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