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RECRUITING Phase 1

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

NCT04077099 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body

Conditions Studied

Interventions

  • DRUG REGN5093

Study Locations (20)

New York

  • NYU Cancer Institute — New York
  • Icahn School of Medicine at Mount Sinai — New York
  • Memorial Sloan Kettering Cancer Center — New York

Massachusetts

  • DNU_Massachusetts General Hospital_DNU — Boston
  • Dana Farber Harvard Cancer Center Consortium — Boston

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia
  • University of Pittsburgh UPMC - Clinical Research Services — Pittsburgh

Texas

  • Harold C. Simmons Comprehensive Cancer Center — Dallas
  • The University of Texas MD Anderson Cancer Center — Houston

Alabama

  • University of Alabama at Birmingham — Birmingham

California

  • University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 — Orange

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Florida

  • Moffitt Cancer Center - McKinley Drive — Tampa

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2020-01-07
Est. Completion 2032-04-22
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04077099

The ClinicalTrials.gov registry entry for NCT04077099 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with NSCLC appearing as the primary indexed condition, and to 1 intervention — of which REGN5093 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04077099 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04077099 about?

NCT04077099 is a clinical study titled "A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer". This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of...

What is the current status of trial NCT04077099?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 231 participants. The study started on 2020-01-07. Estimated completion is 2032-04-22.

What conditions does trial NCT04077099 study?

This clinical trial studies the following conditions: NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04077099?

The interventions under investigation include: REGN5093 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04077099?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04077099 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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