A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body

Purpose

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)

Conditions

  • Melanoma
  • Clear-Cell Renal-Cell Carcinoma (ccRCC)
  • Advanced Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Dose escalation cohorts: 1. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy 2. Participants are required to submit archival tissue if it is available Dose expansion cohorts: 1. 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 2. ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points

Exclusion Criteria

  1. Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy 2. Prior 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 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 4 weeks prior to study intervention, and discontinuation due to grade 3 or 4 toxicities 5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol 6. Has known allergy or hypersensitivity to components of the study drug(s) 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 intervention 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Monotherapy Dose Escalation
Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D)
  • Drug: REGN10597
    Administered per the protocol
Experimental
Phase 2: Monotherapy Dose Expansion
Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants
  • Drug: REGN10597
    Administered per the protocol
Experimental
Phase 1: Combination Dose Escalation
Multiple DL Cohorts to identify the RP2D
  • Drug: REGN10597
    Administered per the protocol
  • Drug: Cemiplimab
    Administered per the protocol
Experimental
Phase 2: Combination Dose Expansion
Cohort 1: Melanoma participants
  • Drug: REGN10597
    Administered per the protocol
  • Drug: Cemiplimab
    Administered per the protocol

Recruiting Locations

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90089

University of California San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143

Yale School of Medicine
North Haven 4839704, Connecticut 4831725 06473

University of Chicago
Chicago 4887398, Illinois 4896861 60637

Start Midwest Cancer Research
Grand Rapids 4994358, Michigan 5001836 49546

Northwell Health
Lake Success 5123853, New York 5128638 11042

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514

University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Next Oncology
San Antonio 4726206, Texas 4736286 78229

The Start Center for Cancer Care
San Antonio 4726206, Texas 4736286 78229

More Details

NCT ID
NCT06413680
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Detailed Description

Phase 1: Conducted in the United States only Phase 2: Conducted globally