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โ† Trials
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A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBayer
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In plain words

What the trial is, and whether it could suit you

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 i

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participant must be โ‰ฅ 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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What it tests

  • BAY 3713372
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Where

63 sites
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

โ€ฆand 55 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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