Study on the Safety and Effectiveness of REGN10597 for Adults with Advanced Solid Tumors
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06413680
This clinical trial is testing a new experimental drug, REGN10597, to see if it is safe and effective for adults with advanced solid tumors. The study will also look at potential side effects and how the body reacts to the drug.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an experimental drug called REGN10597 in adults with advanced solid tumors. Researchers will also investigate what side effects might occur, how the drug is processed in the body, and whether the body develops antibodies against it, which could affect its effectiveness or cause side effects.
Description
The study is divided into two phases: Phase 1 will take place in the United States, and Phase 2 will be conducted globally. The trial aims to determine the best dose of REGN10597 and assess its safety and effectiveness in treating advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic cancer that has progressed after standard treatment.
- Must provide a sample of previous tumor tissue, with an optional fresh biopsy for dose-escalation groups.
- For dose-expansion groups, must have a confirmed diagnosis of Melanoma or clear cell renal cell carcinoma (ccRCC) and provide a fresh biopsy before treatment.
Exclusion Criteria
- Have previously been treated with certain immune therapies like Interleukin 2, 15, or 7.
- Have received anti-cancer treatments like anti PD-1/PD-L1 or other systemic therapies within 4 weeks before starting the study drug.
- Have had radiation therapy or major surgery within 14 days before the first dose of the study drug or have not recovered from side effects of previous treatments.
- Have had any anti-cancer immunotherapy within 2 months before starting the study.
- Have ongoing immune-related side effects before starting the study drug.
- Have known allergies to components of the study drug.
- Require ongoing corticosteroid therapy at doses higher than 10 mg of prednisone per day.
- Have significant autoimmune diseases or conditions requiring systemic immunosuppressive treatments within the last 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Usc Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UCSF | 94143 | San Francisco | California |
| Start Midwest Cancer Research | 49546 | Grand Rapids | Michigan |
| Northwell Health | 11042 | Lake Success | New York |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| Next Oncology | 78229 | San Antonio | Texas |
| The Start Center for Cancer Care | 78229 | San Antonio | Texas |
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