Study on BMS-986504 Alone and with Other Treatments for Advanced Solid Tumors with MTAP Deletion
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07492680
This clinical trial is testing a new drug, BMS-986504, both by itself and in combination with other cancer treatments, for patients with advanced solid tumors that have a specific genetic deletion called MTAP.
Patient Parameters
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Program Overview
This study is exploring the effects of a new drug, BMS-986504, on patients with advanced or metastatic solid tumors that have a genetic deletion known as MTAP. The trial will look at how safe and tolerable the drug is, how it behaves in the body, and its initial effectiveness against tumors. The study includes two parts: one where BMS-986504 is given alone, and another where it is combined with other cancer treatments.
Description
The study is divided into two parts. In Part 1, patients will receive BMS-986504 alone to determine the best dose for specific types of tumors. In Part 2, the drug will be given alongside other cancer treatments to find the best combination dose. Additional groups of patients may be added as new information becomes available. The trial aims to understand how the drug works on its own and in combination with other treatments, focusing on safety, how the drug moves and changes in the body, and its potential to reduce tumors.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor with MTAP gene deletion.
- Have tried standard treatments for their cancer type and stage, but the disease has progressed, or there are no curative treatments available, or the patient is treatment-naïve.
- Have at least one measurable tumor based on specific medical criteria.
- Have normal blood clotting function, with specific limits for those with liver issues.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Have not been treated with PRMT5 or MAT2A inhibitors before.
- Do not have active brain cancer spread or cancer in the brain's lining, unless treated and stable without steroids.
- Do not have recent gastrointestinal issues that could affect drug absorption or swallowing.
- Have adequate organ function based on lab tests.
- Do not have active hepatitis B or C infections.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0096 | 94158 | San Francisco | California |
| Local Institution - 0182 | 80045 | Aurora | Colorado |
| Local Institution - 0178 | 30322 | Atlanta | Georgia |
| Johns Hopkins Hospital | 21287 | Baltimore | Maryland |
| Local Institution - 0124 | 02114 | Boston | Massachusetts |
| Local Institution - 0119 | 48109-0922 | Ann Arbor | Michigan |
| Local Institution - 0129 | 55905 | Rochester | Minnesota |
| Local Institution - 0174 | 55905 | Rochester | Minnesota |
| Local Institution - 0181 | 55905 | Rochester | Minnesota |
| Local Institution - 0142 | 14263 | Buffalo | New York |
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