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

NCT06413680 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: R10597-ONC-221142025-523399-22-00
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 11

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

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)

Outcome Measures

Primary Outcomes (7)

• Incidence of Dose-Limiting Toxicities (DLTs)

  Dose escalation

  Up to Day 29

• Incidence of Treatment-Emergent Adverse Event (TEAEs)

  Dose escalation

  Approximately 6 Years

• Incidence of Serious Adverse Events (SAEs)

  Dose escalation

  Approximately 6 Years

• Incidence of TEAEs leading to treatment discontinuation

  Dose escalation

  Approximately 6 Years

• Incidence of TEAEs leading to death

  Dose escalation

  Approximately 6 Years

• Number of participants with Grade 3 laboratory abnormalities

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

  Approximately 6 Years

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

  Dose expansion

  Approximately 6 Years

Secondary Outcomes (9)

• ORR based on RECIST 1.1 criteria by investigator assessment

  Approximately 6 Years

• Best Overall Response (BOR) based on RECIST 1.1 criteria

  Approximately 6 Years

• Duration Of Response (DOR) based on RECIST 1.1 criteria

  Approximately 6 Years

• Disease control rate based on RECIST 1.1

  Approximately 6 Years

• Time to response based on RECIST 1.1

  Approximately 6 Years

Study Arms (4)

Phase 1: Monotherapy Dose Escalation

EXPERIMENTAL

Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D)

Drug: REGN10597

Phase 2: Monotherapy Dose Expansion

EXPERIMENTAL

Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants

Drug: REGN10597

Phase 1: Combination Dose Escalation

EXPERIMENTAL

Multiple DL Cohorts to identify the RP2D

Drug: REGN10597; Drug: Cemiplimab

Phase 2: Combination Dose Expansion

EXPERIMENTAL

Cohort 1: Melanoma participants

Drug: REGN10597; Drug: Cemiplimab

Interventions

REGN10597 DRUG

Administered per the protocol

Phase 1: Combination Dose Escalation; Phase 1: Monotherapy Dose Escalation; Phase 2: Combination Dose Expansion; Phase 2: Monotherapy Dose Expansion

Cemiplimab DRUG

Administered per the protocol

Phase 1: Combination Dose Escalation; Phase 2: Combination Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dose escalation cohorts:
• \. 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:
• \. 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

You may not qualify if:

• Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
• 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
• Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
• 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
• Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
• Has known allergy or hypersensitivity to components of the study drug(s)
• 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
• Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (11)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

RECRUITING

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Yale School of Medicine

North Haven, Connecticut, 06473, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Start Midwest Cancer Research

Grand Rapids, Michigan, 49546, United States

RECRUITING

Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Next Oncology

San Antonio, Texas, 78229, United States

RECRUITING

The Start Center for Cancer Care

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

• BrILliance

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): February 3, 2030
• Study Completion (Estimated): February 3, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (11)