First-in-Human Study of BAY 3713372 for Treating MTAP-Deleted Solid Tumors
Sponsor: Bayer
ClinicalTrials ID:NCT06914128
This clinical trial is testing a new drug, BAY 3713372, to see if it is safe and effective for treating solid tumors with a specific genetic deletion called MTAP. The study will explore how the drug works in the body and its impact on cancer cells.
Patient Parameters
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Program Overview
The study is investigating a new treatment, BAY 3713372, for solid tumors that have a genetic deletion known as MTAP. This drug is designed to target and kill cancer cells with this deletion while leaving normal cells unharmed. The main goal is to determine how safe the drug is, how the body processes it, and how well it works in people with these tumors. Researchers will monitor participants for side effects, how the drug is absorbed in the body, and its effectiveness in controlling cancer. Participants will be divided into groups to receive different doses to find the safest and most effective dose. Once the best dose is identified, more participants will receive the drug alone or with other treatments. Participants will continue treatment as long as they benefit without severe side effects. Regular visits and tests will be conducted to monitor health and cancer progression.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have at least one measurable tumor that can be tracked using standard criteria.
- Have a specific genetic deletion called MTAP, confirmed by a lab test.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have had another type of cancer within the past 2 years, except for certain non-threatening cancers like treated skin cancer or localized prostate cancer.
- Have a heart condition that causes a prolonged QT interval on an ECG, unless you have a pacemaker and your doctor approves participation.
- Have a history of heart failure worse than Class II, recent heart attack, or serious heart rhythm problems.
- Have had unstable chest pain within 4 weeks before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's | 80218 | Denver | Colorado |
| Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona | 32827 | Orlando | Florida |
| START | Midwest | 49546 | Grand Rapids | Michigan |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| NEXT Dallas - Oncology Department | 75039 | Irving | Texas |
| START | San Antonio | 78229 | San Antonio | Texas |
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