A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies

Launched by REGENERON PHARMACEUTICALS · May 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new experimental drug called REGN10597 to see if it is safe and how well it works for adults with advanced solid tumors, such as melanoma and clear-cell renal-cell carcinoma. The trial aims to learn about any side effects the drug might cause, how the body processes the drug, and whether the body creates antibodies against it, which could affect how well the drug works.

To participate, you need to have a confirmed diagnosis of a specific type of cancer that has not responded to standard treatments. You will also need to provide a tissue sample for testing. Participants will receive the study drug and be monitored closely by the research team for any effects or changes in health. This study is currently recruiting patients aged 65 to 74, and all genders are welcome to apply. If you meet the eligibility criteria and are interested, it could be a chance to contribute to important research while receiving care.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• Dose-escalation cohorts:
• • 1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
• • 2. Participants are required to submit archival tissue with optional fresh biopsy
• Dose-expansion cohorts:
• • 1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol
• • 2. Participants are required to submit fresh pretreatment biopsy during screening
• Key Exclusion Criteria:
• • 1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7
• • 2. Prior treatment with anti PD-1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
• • 3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
• • 4. Has had prior anti-cancer immunotherapy within 2 months prior to study therapy
• • 5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol
• • 6. Has known allergy or hypersensitivity to components of the study drug
• • 7. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study drug
• • 8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments
• • NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.