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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04077099
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5093 — DRUG
    Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Study Details

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

Key Dates

Start date
Jan 7, 2020
Status verified
Mar 2026
Primary completion
Apr 22, 2032
Completion
Apr 22, 2032

Study Design

Enrollment
231 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: REGN5093
    Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)

Primary Outcome Measure

Number of patients with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241OrangeCalifornia92868-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Moffitt Cancer Center - McKinley DriveTampaFlorida33612-
University of Kentucky, Markey Cancer Center Clinical Research OrganizationLexingtonKentucky40536-
Dana Farber Harvard Cancer Center ConsortiumBostonMassachusetts02215-
DNU_Massachusetts General Hospital_DNUBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Cancer InstituteNew YorkNew York10016-
Duke Cancer CenterDurhamNorth Carolina27710-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Pittsburgh UPMC - Clinical Research ServicesPittsburghPennsylvania15232-
Harold C. Simmons Comprehensive Cancer CenterDallasTexas75235-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California Irvine Medical Center - Bldg 56, RT81, Rm 241· Orange, CAGeorgetown University Medical Center· Washington D.C., DCMoffitt Cancer Center - McKinley Drive· Tampa, FLUniversity of Kentucky, Markey Cancer Center Clinical Research Organization· Lexington, KYDana Farber Harvard Cancer Center Consortium· Boston, MA

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