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
Condition(s) studied
Investigational drug(s) / intervention(s)
REGN10597: Administered per the protocol
Cemiplimab: Administered per the protocol
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)
Eligibility
Primary outcome measure(s)
- Incidence of Dose-Limiting Toxicities (DLTs) — Up to Day 29
Dose escalation - Incidence of Treatment-Emergent Adverse Event (TEAEs) — Approximately 6 Years
Dose escalation - Incidence of Serious Adverse Events (SAEs) — Approximately 6 Years
Dose escalation - Incidence of TEAEs leading to treatment discontinuation — Approximately 6 Years
Dose escalation - Incidence of TEAEs leading to death — Approximately 6 Years
Dose escalation - Number of participants with Grade 3 laboratory abnormalities — Approximately 6 Years
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 - Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment — Approximately 6 Years
Dose expansion
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| University of California San Francisco (UCSF) | San Francisco | California | Recruiting |
| Yale School of Medicine | North Haven | Connecticut | Recruiting |
| University of Chicago | Chicago | Illinois | Recruiting |
| Start Midwest Cancer Research | Grand Rapids | Michigan | Recruiting |
| Northwell Health | Lake Success | New York | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Next Oncology | San Antonio | Texas | Recruiting |
| The Start Center for Cancer Care | San Antonio | Texas | Recruiting |
On this site
📄 Libtayo (cemiplimab) drug profile →More Regeneron Pharmaceuticals trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06413680 on ClinicalTrials.gov ↗ ← All trials in the USA