Back to Trials
NCT06413680PHASE1, PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

9/23/2024

Completion Date

2/3/2030

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)

Detailed Description

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

REGN10597

DRUG

Cemiplimab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

MelanomaClear-Cell Renal-Cell Carcinoma (ccRCC)Advanced Solid Tumors

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California 90089

United States

University of California San Francisco (UCSF)

San Francisco, California 94143

United States

Yale School of Medicine

North Haven, Connecticut 06473

United States

University of Chicago

Chicago, Illinois 60637

United States

Start Midwest Cancer Research

Grand Rapids, Michigan 49546

United States

Northwell Health

Lake Success, New York 11042

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Next Oncology

San Antonio, Texas 78229

United States

The Start Center for Cancer Care

San Antonio, Texas 78229

United States