A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called study drug(s)). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug(s) are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
∙ Dose escalation cohorts:
• Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
• Participants are required to submit archival tissue if it is available
∙ Dose expansion cohorts:
• Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
‣ Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
⁃ Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
⁃ Module 2, Cohort 1: 1L Melanoma
• ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points