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NCT06413680 · ClinicalTrials.gov registry record · Phase 1

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 study of Melanoma and Advanced Solid Tumors, sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
240
Enrollment target
11
Study locations

NCT06413680 is a Phase 1 study of Melanoma and Advanced Solid Tumors that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 240 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (66% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT06413680, a Phase 1 study of Melanoma and Advanced Solid Tumors, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
240 participants
Enrollment target
11
Study locations

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)

Interventions

  • DRUG Cemiplimab
  • DRUG REGN10597

Study Locations (11)

Texas

  • MD Anderson Cancer Center - Houston
  • Next Oncology - San Antonio
  • The Start Center for Cancer Care - San Antonio

California

  • USC Norris Comprehensive Cancer Center - Los Angeles
  • University of California San Francisco (UCSF) - San Francisco

Connecticut

  • Yale School of Medicine - North Haven

Illinois

  • University of Chicago - Chicago

Michigan

  • Start Midwest Cancer Research - Grand Rapids

New York

  • Northwell Health - Lake Success

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Pennsylvania

  • University of Pittsburgh Medical Center - Hillman Cancer Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2024-09-23
Est. Completion 2030-02-03
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT06413680

The ClinicalTrials.gov registry entry for NCT06413680 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (66% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.

NCT06413680 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Texas, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT06413680 about?

NCT06413680 is a clinical study titled "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". 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 eff...

What is the current status of trial NCT06413680?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2024-09-23. Estimated completion is 2030-02-03.

What conditions does trial NCT06413680 study?

This clinical trial studies the following conditions: Melanoma, Advanced Solid Tumors, Clear Cell Renal Cell Carcinoma (ccRCC).

What interventions are being tested in trial NCT06413680?

The interventions under investigation include: Cemiplimab (DRUG), REGN10597 (DRUG).

Who is sponsoring clinical trial NCT06413680?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06413680 being conducted?

This trial has 11 study locations across California, Connecticut, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.