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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
NCT06413680 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Cemiplimab
- DRUG REGN10597
Study Locations (11)
Texas
- MD Anderson Cancer Center — Houston
- Next Oncology — San Antonio
- The Start Center for Cancer Care — San Antonio
California
- USC Norris Comprehensive Cancer Center — Los Angeles
- University of California San Francisco (UCSF) — San Francisco
Connecticut
- Yale School of Medicine — North Haven
Illinois
- University of Chicago — Chicago
Michigan
- Start Midwest Cancer Research — Grand Rapids
New York
- Northwell Health — Lake Success
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Pennsylvania
- University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2030-02-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06413680
The ClinicalTrials.gov registry entry for NCT06413680 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06413680 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Texas, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06413680 about?
NCT06413680 is a clinical study titled "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". 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 eff...
What is the current status of trial NCT06413680?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2024-09-23. Estimated completion is 2030-02-03.
What conditions does trial NCT06413680 study?
This clinical trial studies the following conditions: Melanoma, Advanced Solid Tumors, Clear-Cell Renal-Cell Carcinoma (ccRCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06413680?
The interventions under investigation include: Cemiplimab (DRUG), REGN10597 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06413680?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06413680 being conducted?
This trial has 11 study locations across California, Connecticut, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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