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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06413680
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN10597 — DRUG
    Administered per the protocol
  • Cemiplimab — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

Start date
Sep 23, 2024
Status verified
Apr 2026
Primary completion
Feb 3, 2030
Completion
Feb 3, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to Day 29 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90089-
University of California San Francisco (UCSF)San FranciscoCalifornia94143-
Yale School of MedicineNorth HavenConnecticut06473-
University of ChicagoChicagoIllinois60637-
Start Midwest Cancer ResearchGrand RapidsMichigan49546-
Northwell HealthLake SuccessNew York11042-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
MD Anderson Cancer CenterHoustonTexas77030-
Next OncologySan AntonioTexas78229-
The Start Center for Cancer CareSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California San Francisco (UCSF)· San Francisco, CAYale School of Medicine· North Haven, CTUniversity of Chicago· Chicago, ILStart Midwest Cancer Research· Grand Rapids, MINorthwell Health· Lake Success, NY

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