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
Public ClinicalTrials.gov record NCT06413680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
Study identification
- NCT ID
- NCT06413680
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Regeneron Pharmaceuticals
- Industry
- Enrollment
- 240 participants
Conditions and interventions
Interventions
- Cemiplimab Drug
- REGN10597 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 22, 2024
- Primary completion
- Feb 2, 2030
- Completion
- Feb 2, 2030
- Last update posted
- Apr 27, 2026
2024 – 2030
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | Recruiting |
| University of California San Francisco (UCSF) | San Francisco | California | 94143 | Recruiting |
| Yale School of Medicine | North Haven | Connecticut | 06473 | Recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| Start Midwest Cancer Research | Grand Rapids | Michigan | 49546 | Recruiting |
| Northwell Health | Lake Success | New York | 11042 | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Recruiting |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Next Oncology | San Antonio | Texas | 78229 | Recruiting |
| The Start Center for Cancer Care | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06413680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2026 · Synced May 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06413680 live on ClinicalTrials.gov.