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NCT06413680 | RECRUITING | Melanoma

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
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)

Condition or disease

Melanoma

Clear-Cell Renal-Cell Carcinoma (ccRCC)

Advanced Solid Tumors

Intervention/treatment

REGN10597

Phase

PHASE1

PHASE2

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) in Patients With Advanced Solid Organ Malignancies
Actual Study Start Date : 2024-09-23
Estimated Primary Completion Date : 2030-02-03
Estimated Study Completion Date : 2030-02-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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.
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

Location Details

NCT06413680

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

UCSF

San Francisco, California, United States, 94143

RECRUITING

United States, Connecticut

Yale School of Medicine

North Haven, Connecticut, United States, 06511

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Road cancer

Start Midwest Cancer Research

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, New York

Northwell Health

Lake Success, New York, United States, 11042

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Next Oncology

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

The Start Center for Cancer Care

San Antonio, Texas, United States, 78229