RecruitingRecruiting
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
NCT04077099 · Regeneron Pharmaceuticals
In plain English
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Official title
A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
About this study
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
Eligibility criteria
Key Inclusion Criteria:
1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
2. Willing to provide tumor tissue as described in the protocol
3. Documented presence of MET alteration as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ and bone marrow function as described in the protocol
Key Exclusion Criteria:
1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
3. Has received radiation therapy or major surgery within 14 days as described in the protocol
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
5. Uncontrolled infection as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria apply
Study design
Enrollment target: 231 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-01-07
Estimated completion: 2032-04-22
Last updated: 2026-03-18
Interventions
Drug: REGN5093
Primary outcomes
- • Number of patients with Dose Limiting Toxicities (DLTs) (Up to 21 days)
- • Incidence and severity of treatment-emergent adverse events (TEAEs) (Through study completion, an average of 12 years)
- • Incidence and severity of adverse events of special interest (AESIs) (Through study completion, an average of 12 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (40)
University of Alabama at BirminghamWithdrawn
Birmingham, Alabama, United States
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241Completed
Orange, California, United States
Georgetown University Medical CenterCompleted
Washington D.C., District of Columbia, United States
Moffitt Cancer Center - McKinley DriveRecruiting
Tampa, Florida, United States
University of Kentucky, Markey Cancer Center Clinical Research OrganizationWithdrawn
Lexington, Kentucky, United States
DNU_Massachusetts General Hospital_DNUWithdrawn
Boston, Massachusetts, United States
Dana Farber Harvard Cancer Center ConsortiumCompleted
Boston, Massachusetts, United States
Henry Ford Health SystemWithdrawn
Detroit, Michigan, United States
Washington University School of MedicineWithdrawn
St Louis, Missouri, United States
NYU Cancer InstituteWithdrawn
New York, New York, United States
Icahn School of Medicine at Mount SinaiCompleted
New York, New York, United States
Memorial Sloan Kettering Cancer CenterCompleted
New York, New York, United States
Duke Cancer CenterWithdrawn
Durham, North Carolina, United States
Stephenson Cancer CenterWithdrawn
Oklahoma City, Oklahoma, United States
Fox Chase Cancer CenterWithdrawn
Philadelphia, Pennsylvania, United States
University of Pittsburgh UPMC - Clinical Research ServicesCompleted
Pittsburgh, Pennsylvania, United States
Harold C. Simmons Comprehensive Cancer CenterWithdrawn
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Centre Georges Francois LeclercWithdrawn
Dijon, Bourgogne-Franche-Comté, France
Centre Hospitalier Universitaire de Rennes - Hopital PontchaillouCompleted
Rennes, Bretange, France
Institut BergonieCompleted
Bordeaux, New Aquitaine, France
Centre Francois Baclesse (CFB)Completed
Caen, Normandy, France
Centre Hospitalier Universitaire de GrenobleCompleted
Grenoble, France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveCompleted
Montpellier, France
National Cancer CenterRecruiting
Gyeonggi-do, Gyeonggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University Of Korea St. Vincent's HospitalRecruiting
Suwon, Gyeonggi-do, South Korea
Ajou University HospitalRecruiting
Suwon, Gyeonggi-do, South Korea
Haeundae Paik HospitalRecruiting
Pusan, Gyeongsangnam-do, South Korea
Chonnam National University Hwasun HospitalRecruiting
Hwasun, Jeollanam-do, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, Namdong-gu, South Korea
Chungbuk National University HospitalRecruiting
Cheongju-si, North Chungcheong, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seol St. Mary's HospitalCompleted
Seoul, South Korea
Boramae Medical CenterRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance HospitalRecruiting
Seoul, South Korea