Recruiting
Phase 1
Phase 2

REGN10597

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06413680

Conditions

Melanoma

Clear-Cell Renal-Cell Carcinoma (ccRCC)

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN10597

Cemiplimab

Study Details

Brief summary:

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

Study ID

NCT06413680

Start date

Sep 23, 2024

Status verified date

Apr, 2026

Completion date

Feb 3, 2030

Anticipated

Primary completion date

Feb 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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. 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 ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points

Key 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, or discontinuation of prior anti-cancer immunotherapy 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

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

REGN10597

Administered per the protocol

Cemiplimab

Administered per the protocol

Primary outcome measure

  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to Day 29 ]
  • Incidence of Treatment-Emergent Adverse Event (TEAEs) [ Time Frame: Approximately 6 Years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 6 Years ]
  • Incidence of TEAEs leading to treatment discontinuation [ Time Frame: Approximately 6 Years ]
  • Incidence of TEAEs leading to death [ Time Frame: Approximately 6 Years ]
  • Number of participants with Grade 3 laboratory abnormalities [ Time Frame: Approximately 6 Years ]
  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment [ Time Frame: Approximately 6 Years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

University of California San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

Yale School of Medicine

Recruiting

North Haven, Connecticut, United States, 06473

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Start Midwest Cancer Research

Recruiting

Grand Rapids, Michigan, United States, 49546

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

University of Pittsburgh Medical Center - Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Next Oncology

Recruiting

San Antonio, Texas, United States, 78229

The Start Center for Cancer Care

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Advanced solid organ malignancies
  • Locally advanced
  • Metastatic
  • Non-uveal
  • Unresectable
  • Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-04-28.