Trials / Recruiting
RecruitingNCT06413680
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 1/2a, 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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed description
Phase 1: Conducted in the United States only Phase 2: Conducted globally
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REGN10597 | Administered per the protocol |
| DRUG | Cemiplimab | Administered per the protocol |
Timeline
- Start date
- 2024-09-23
- Primary completion
- 2030-02-03
- Completion
- 2030-02-03
- First posted
- 2024-05-14
- Last updated
- 2025-12-15
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06413680. Inclusion in this directory is not an endorsement.