Recruiting PHASE1, PHASE2 MTAP-deleted Solid Tumors

New treatment option for MTAP-deleted Solid Tumors

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

ClinicalTrials.gov ID: NCT06914128

What this study is testing

What is BAY 3713372?

BAY 3713372 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mtap-deleted solid tumors.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • 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.

You likely can't join if

  • 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...
  • A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval \>450 ms). Participants with permanent...
  • 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...
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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...
  • 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...
  • 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...
  • Unstable angina within 4 weeks before start of study intervention.

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Orlando, Florida, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • New York, New York, United States
  • Nashville, Tennessee, United States
  • Irving, Texas, United States
  • San Antonio, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Camperdown, New South Wales, Australia
  • Concord, New South Wales, Australia
  • Epping, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Antwerp, Antwerp, Belgium

+ 34 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Aurora, Colorado, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.