Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-04-28
240
Participants Needed
11
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically or cytologically confirmed advanced or metastatic solid tumors with progression after standard therapy
- Participants in dose escalation cohorts must submit archival tissue if available
- Participants in dose expansion cohorts must have confirmed melanoma or renal-cell carcinoma as defined by the protocol
- Participants in dose expansion cohorts must submit fresh pretreatment biopsy and may provide additional biopsies during treatment
You will not qualify if you...
- Prior treatment with Interleukin 2 (IL2), IL15, or IL-7 outside adoptive cell therapy
- Prior treatment with anti-PD1/PD-L1 or other systemic therapies within 4 weeks
- Radiation therapy or major surgery within 14 days before the first study drug dose or unresolved adverse events
- Prior anti-cancer immunotherapy within 4 weeks or discontinuation due to severe toxicities
- Ongoing immune-related adverse events before starting study treatment
- Known allergy or hypersensitivity to study drug components
- Ongoing or recent corticosteroid therapy exceeding 10 mg prednisone daily
- Recent or ongoing autoimmune disease requiring systemic immunosuppressive treatment within 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
3
Yale School of Medicine
North Haven, Connecticut, United States, 06473
Actively Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Start Midwest Cancer Research
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
8
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Next Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
11
The Start Center for Cancer Care
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here