A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies

Phase 1

Recruiting

• Conditions: Clear-Cell Renal-Cell Carcinoma (ccRCC); Advanced Solid Tumors; Melanoma
• Interventions: Drug: REGN10597

• Registration Number: NCT06413680
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This study is researching an experimental drug called REGN10597 (called "study drug"). 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 is.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug

* How much study drug is in the blood at different times

* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Study Start: 2024-09-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2030-02-03
• Study Completion: 2030-02-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Dose-escalation cohorts:

1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
2. Participants are required to submit archival tissue with optional fresh biopsy

Dose-expansion cohorts:

1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol
2. Participants are required to submit fresh pretreatment biopsy during screening

Key

Exclusion Criteria

1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7
2. Prior treatment with anti PD-1/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 2 months prior to study therapy
5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol
6. Has known allergy or hypersensitivity to components of the study drug
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 drug
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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1: Dose Escalation	REGN10597	Multiple dose level (DL) Cohorts to identify the recommended Phase 2 dose (RP2D)
Phase 2: Dose Expansion	REGN10597	Cohort 1: Melanoma Participants Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	Approximately 6 Years
Incidence of TEAEs leading to treatment discontinuation	Approximately 6 Years
Incidence of dose-limiting toxicities (DLTs)	Up to Day 28
Incidence of TEAEs leading to death	Approximately 6 Years
Incidence of treatment-emergent adverse event (TEAEs)	Approximately 6 Years
Number of participants with Grade ≥3 laboratory abnormalities	Approximately 6 Years	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 assessment	Approximately 6 Years	Dose-expansion

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR) based on RECIST 1.1 criteria	Approximately 6 Years
Time to response based on RECIST 1.1	Approximately 6 Years
Concentrations of REGN10597 in serum	Approximately 6 Years
Incidence of anti-drug antibody (ADA) to REGN10597 over time	Approximately 6 Years
Best overall response (BOR) based on RECIST 1.1 criteria	Approximately 6 Years
Progression free survival (PFS) based on RECIST 1.1	Approximately 6 Years
ORR based on RECIST 1.1 criteria by investigator assessment	Approximately 6 Years	Dose-escalation
Disease control rate based on RECIST 1.1	Approximately 6 Years
Titer of ADA to REGN10597 over time	Approximately 6 Years

Trial Locations

Locations (11)

Yale School of Medicine; 🇺🇸 North Haven, Connecticut, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Pittsburgh Medical Center - Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Usc Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

Start Midwest Cancer Research; 🇺🇸 Grand Rapids, Michigan, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Next Oncology; 🇺🇸 San Antonio, Texas, United States

The Start Center for Cancer Care; 🇺🇸 San Antonio, Texas, United States