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
Recruiting · Phase 1, Phase 2 · NCT06413680
Conditions: Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
At a glance
- Research payments reported, 2025
- $1.8M
- U.S. investigators named
- 12
- Sites paid
- 11
- Planned or actual enrollment
- 240
About the trial
- Sponsor
- Regeneron Pharmaceuticals
- Tested
- REGN10597 (drug), Cemiplimab (drug)
- Dates
- Started 2024-09-23; completion 2030-02-03
- Results posted
- Not yet
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)
From ClinicalTrials.gov, last updated 2026-04-28. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $1.8M in research payments for this study in 2025 (263 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Anthony B. El-khoueiry, M.D. Medical Oncology · Los Angeles, CA
- Michael E. Hurwitz, MD PHD Medical Oncology · New Haven, CT
- Adil Daud, MD Medical Oncology · Tampa, FL
- Randy Sweis Hematology & Oncology · Chicago, IL
- Nehal J. Lakhani, M.D. Hematology & Oncology · Grand Rapids, MI
- Tracy L. Rose, M.D. Internal Medicine · Chapel Hill, NC
- Shaheer A. Khan, DO Medical Oncology · New York, NY
- Diwakar Davar Hematology & Oncology · Pittsburgh, PA
- Rodabe Amaria, MD Medical Oncology · Houston, TX
- Adi Diab, M.D Medical Oncology · Houston, TX
- Kyriakos P. Papadopoulos, M.D. Hematology & Oncology · San Antonio, TX
- Ildefonso I. Rodriguez-rivera, M.D. Hematology & Oncology · San Antonio, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- South Texas Accelerated Research Therapeutics LLC $462,403
- Start Midwest LLC $369,175
- Ut MD Anderson Cancer Center $186,981
- The Feinstein Institutes for Medical Research $132,368
- Yale University $130,743
- The University of North Carolina at Chapel Hill $109,409
- The University of Chicago $94,716
- University of Pittsburgh Cancer Institute Cancer Services $93,734
- University of Southern California $79,418
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $75,479
- New Experimental Therapeutics of San Antonio LLC $32,812
- $8,482
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.