Actively Recruiting
A Phase 1/2a Open-Label Study of REGN10597 Alone or With Cemiplimab in Adults With Advanced Solid Tumors
Led by Regeneron Pharmaceuticals · Updated on 2026-04-28
240
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called REGN10597, given alone or with another drug called cemiplimab, in adults with advanced solid tumors such as melanoma and clear-cell renal-cell carcinoma. This Phase 1/2a trial aims to evaluate how safe, tolerable, and effective these study drugs are in treating cancers that have spread in the body. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the drugs that might affect their activity or cause side effects. Participants receive REGN10597 alone or combined with cemiplimab in different dose levels to find the best dose for future studies. The study includes dose escalation and dose expansion phases, with separate groups for melanoma and renal-cell carcinoma patients. Dosing and administration follow the study protocol, and participants may have biopsies at screening and other times for research purposes. During the study, participants will be monitored closely for side effects and treatment responses. Researchers assess tumor response using established criteria and track various safety outcomes over approximately six years. Blood samples are collected to measure drug concentrations and antibody development. Participants will have regular visits for evaluations, and their health status will be followed for a long-term period to understand treatment effects and safety.
CONDITIONS
Brief 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 aged 18 years or older
- Confirmed diagnosis of locally advanced or metastatic solid malignancy with progression on standard therapy
- For dose expansion: confirmed melanoma or renal-cell carcinoma as defined in the protocol
- Ability to provide archival or fresh tumor tissue as required
- Willingness to undergo biopsies at screening and other time points as applicable
You will not qualify if you...
- Prior treatment with IL2, IL15, or IL-7 outside concurrent adoptive cell therapy
- Prior treatment with anti-PD1/PD-L1 or systemic non-immunomodulatory biologic therapy within 4 weeks
- Recent radiation therapy or major surgery within 14 days before first study drug dose
- Prior anti-cancer immunotherapy within 4 weeks or discontinuation due to severe toxicities
- Ongoing immune-related adverse events before study start
- Known allergy or hypersensitivity to study drug components
- Use of corticosteroids above 10 mg prednisone daily within 1-2 weeks before study
- Recent or ongoing significant autoimmune disease requiring systemic immunosuppression within 5 years
- Other protocol-defined exclusions as detailed in the study documents without further specification here
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 years
Participants receive REGN10597 alone or in combination with Cemiplimab as per the protocol to treat advanced solid tumors.
Visits scheduled according to dosing and assessment requirements over the treatment period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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