Purpose

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)

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Dose Escalation
Multiple dose level (DL) Cohorts to identify the recommended Phase 2 dose (RP2D)
  • Drug: REGN10597
    Administered as an intravenous (IV) infusion
Experimental
Phase 2: Dose Expansion
Cohort 1: Melanoma Participants Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants
  • Drug: REGN10597
    Administered as an intravenous (IV) infusion

Recruiting Locations

Usc Norris Comprehensive Cancer Center
Los Angeles, California 90033

University of California San Francisco (UCSF)
San Francisco, California 94143

Yale School of Medicine
North Haven, Connecticut 06511

University of Chicago
Chicago, Illinois 60637

Start Midwest Cancer Research
Grand Rapids, Michigan 49546

Northwell Health
Lake Success, New York 11042

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599

University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

MD Anderson Cancer Center
Houston, Texas 77030

Next Oncology
San Antonio, Texas 78229

The Start Center for Cancer Care
San Antonio, Texas 78229

More Details

NCT ID
NCT06413680
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.