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NCT06413680 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Melanoma and Advanced Solid Tumors, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 240
- Enrollment target
- 11
- Study locations
NCT06413680: Recruiting Phase 1 study of Melanoma and Advanced Solid Tumors, sponsored by Regeneron Pharmaceuticals.
NCT06413680 is a Phase 1 study of Melanoma and Advanced Solid Tumors that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 240 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (66% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06413680, a Phase 1 study of Melanoma and Advanced Solid Tumors, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 240 participants
- Enrollment target
- 11
- Study locations
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)
Primary Outcome
Dose escalation
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 |
What NCT06413680 shows while recruiting
NCT06413680 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (66% lower).
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.
NCT06413680 lists 11 locations in 8 states (Texas, California, Connecticut).
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).
What interventions are being tested in trial NCT06413680?
The interventions under investigation include: Cemiplimab (DRUG), REGN10597 (DRUG).
Who is sponsoring clinical trial NCT06413680?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06413680's enrollment target sits among peer trials
240 64th of 266 higher than 203 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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