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

Eligibility Criteria

• 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
• 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
• 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