Trial intelligence / Profile preview

First-in-human study of REGN10597 alone or with cemiplimab in advanced solid tumors

2025-523399-22-00Phase 2Authorised

Sponsor
Regeneron Pharmaceuticals
Start
May 2026
Modality
Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Immunomodulatory ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Countries
5
01

Overview

Phase 2, open-label trial of REGN10597 and cemiplimab in Nonhematologic neoplasms, melanoma and clear cell renal cell carcinoma (ccRCC) (2 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Incidence of dose-limiting toxicities, Incidence of treatment-emergent adverse events and 5 more. Planned start May 2026; status: authorised.

02

Drugs

REGN10597cemiplimab
03

Conditions

Nonhematologic neoplasmsmelanomaclear cell renal cell carcinoma (ccRCC)

Beyond the preview

Go deeper on 2025-523399-22-00.

Study design, results and competitive context are available in the Gosset platform where reported.

Study design & results

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on 2025-523399-22-00.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call