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NCT06413680

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~240 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:REGN10597Cemiplimab

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs)
Measured over Up to Day 29
+6 more outcomes measured

Conditions

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

Explore related trials

MelanomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

11 sites across 8 states
Texas3
California2
Connecticut1
Illinois1
Michigan1
New York1
North Carolina1
Pennsylvania1

Study leadership

  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

Who to contact

Clinical Trials Administrator
[email protected]
844-734-6643
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Eligibility criteria

Inclusion

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

What this trial measures

  • Incidence of Dose-Limiting Toxicities (DLTs)Up to Day 29

    Dose escalation

  • Incidence of Treatment-Emergent Adverse Event (TEAEs)Approximately 6 Years

    Dose escalation

  • Incidence of Serious Adverse Events (SAEs)Approximately 6 Years

    Dose escalation

  • Incidence of TEAEs leading to treatment discontinuationApproximately 6 Years

    Dose escalation

  • Incidence of TEAEs leading to deathApproximately 6 Years

    Dose escalation

  • Number of participants with Grade 3 laboratory abnormalitiesApproximately 6 Years

    Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessmentApproximately 6 Years

    Dose expansion