A Phase I/IIa, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) in Patients With Advanced Solid Organ Malignancies
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Study Summary
This study is researching an experimental drug called REGN10597 (called "study drug"). 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 is.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug 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 therapyParticipants are required to submit archival tissue if it is availableDose 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 orModule 1, Cohort 2: anti-PD-(L)1 Progressed RCC orModule 2, Cohort 1: 1L MelanomaALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
- Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapyPrior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocolHas received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEsHas had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, and discontinuation due to grade 3 or 4 toxicitiesHas ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocolHas known allergy or hypersensitivity to components of the study drug(s)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 interventionHas ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments
Clinical Study Information for Healthcare Providers
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