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

← catalyst calendar

NCT06413680 · readout in 1,264 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

240estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-09-23

actual

When the study began enrolling

Primary completion

2030-02-03

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-02-03

estimated

The whole study's end, after follow-up

First posted

2024-05-14

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-28

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Melanoma
Clear-Cell Renal-Cell Carcinoma (ccRCC)
Advanced Solid Tumors

Interventions

Drug: REGN10597
Drug: Cemiplimab

Primary outcomes

what the primary-completion date above is the date OF

Incidence of Dose-Limiting Toxicities (DLTs)

measured Up to Day 29

Incidence of Treatment-Emergent Adverse Event (TEAEs)