Testing the safety of BAY 3713372 in patients with specific solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study evaluates the safety and dosage of BAY 3713372, a treatment aimed at patients with MTAP-deleted solid tumors. The study will assess the occurrence and severity of adverse events and dose-limiting toxicities in participants receiving varying doses of the drug. By identifying a safe dosage, the research aims to pave the way for future studies targeting different cancer types with similar genetic deletions. Participants must have previously exhausted standard treatment options.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSF Helen Diller Medical Center at Parnassus Heights - Neurology
  San Francisco, California, United States Recruiting
• Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
  Denver, Colorado, United States Recruiting
• Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
  Orlando, Florida, United States Recruiting
• Massachusetts General Hospital - Neurology
  Boston, Massachusetts, United States Recruiting
• START | Midwest
  Grand Rapids, Michigan, United States Recruiting
• Icahn School of Medicine at Mount Sinai - Oncology
  New York, New York, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PEP08 for adults with advanced MTAP‑deleted solid tumors

  This trial will test whether PEP08, given alone or with another cancer drug, is safe and shows signs of benefit in adults with advanced or metastatic solid tumors that have MTAP deletion.

  Recruiting at 4 sites Phase 1 PharmaEngine · Wentworthville, New South Wales and 3 other locations · NCT06973863

• Testing AZD3470 in patients with advanced solid tumors lacking MTAP.

  This study is testing a new drug called AZD3470 to see if it can help people with advanced solid tumors that lack a specific protein and who haven't had success with other treatments.

  Recruiting at 18 sites Phase 1/2 AstraZeneca · San Francisco, California and 20 other locations · NCT06130553

• Testing GH56 Capsules in Patients with Advanced Solid Tumors Lacking MTAP Gene

  This study is testing GH56 capsules to see if they can help people with advanced solid tumors that lack the MTAP gene and have already tried other treatments without success.

  Recruiting at 23 sites Phase 1 Suzhou Genhouse Bio Co., Ltd. · Beijing, Beijing Municipality and 24 other locations · NCT06796699

• SY-9453 for advanced solid tumors with homozygous MTAP deletion

  This trial will test whether the oral drug SY-9453 is safe and shows anti-tumor activity in adults with advanced or metastatic solid tumors that have a homozygous MTAP deletion.

  Recruiting Phase 1 Shouyao Holdings (Beijing) Co. LTD · Shanghai · NCT07469982

• Evaluating a new drug for advanced solid tumors with a specific genetic deletion

  This study is testing a new drug for people with advanced solid tumors that have a specific genetic change to see how the drug works in their bodies.

  Recruiting at 3 sites Phase 1 Bristol-Myers Squibb · Budapest and 2 other locations · NCT06672523

• BMS-986504 plus chemotherapy for MTAP-deleted pancreatic cancer

  This trial tests whether adding BMS-986504 to standard chemotherapy (and surgery when appropriate) can help control MTAP-deleted pancreatic cancer in adults.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07283705

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.