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

NCT04077099 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: R5093-ONC-18632019-001908-382023-506248-18-00
• Study Type: interventional
• Target: 231
• Locations: 3 countries
• Sites: 40

Brief 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

NSCLC

Keywords

MET (mesenchymal-epithelial transition factor); HGF (Hepatocyte Growth Factor); NSCLC (non-small cell lung cancer); MET-altered advanced; Unresectable; Metastatic disease

Outcome Measures

Primary Outcomes (7)

• Number of patients with Dose Limiting Toxicities (DLTs)

  Phase 1/Dose escalation

  Up to 21 days

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Phase 1/Dose escalation

  Through study completion, an average of 12 years

• Incidence and severity of adverse events of special interest (AESIs)

  Phase 1/Dose escalation

  Through study completion, an average of 12 years

• Incidence and severity of serious adverse events (SAEs)

  Phase 1/Dose escalation

  Through study completion, an average of 12 years

• Incidence and severity of grade ≥3 laboratory abnormalities

  Phase 1/Dose escalation

  Through study completion, an average of 12 years

• REGN5093 concentrations in serum over time

  Phase 1/Dose escalation

  Through study completion, an average of 12 years

• Objective response rate (ORR) per RECIST 1.1

  Phase 2/Dose expansion

  Through study completion, an average of 12 years

Secondary Outcomes (14)

• ORR per RECIST 1.1

  Through study completion, an average of 12 years

• Incidence and severity of TEAEs

  Through study completion, an average of 12 years

• Incidence and severity of AESIs

  Through study completion, an average of 12 years

• Incidence and severity of SAEs

  Through study completion, an average of 12 years

• Incidence and severity of grade ≥3 laboratory abnormalities

  Through study completion, an average of 12 years

Study Arms (1)

REGN5093

EXPERIMENTAL

Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)

Drug: REGN5093

Interventions

REGN5093 DRUG

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

REGN5093

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
• Willing to provide tumor tissue as described in the protocol
• Documented presence of MET alteration as described in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and bone marrow function as described in the protocol

You may not qualify if:

• 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
• Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
• Has received radiation therapy or major surgery within 14 days as described in the protocol
• Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
• Uncontrolled infection as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (40)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

WITHDRAWN

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

Orange, California, 92868, United States

COMPLETED

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

COMPLETED

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, 33612, United States

RECRUITING

University of Kentucky, Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, 40536, United States

WITHDRAWN

DNU_Massachusetts General Hospital_DNU

Boston, Massachusetts, 02114, United States

WITHDRAWN

Dana Farber Harvard Cancer Center Consortium

Boston, Massachusetts, 02215, United States

COMPLETED

Henry Ford Health System

Detroit, Michigan, 48202, United States

WITHDRAWN

Washington University School of Medicine

St Louis, Missouri, 63110, United States

WITHDRAWN

NYU Cancer Institute

New York, New York, 10016, United States

WITHDRAWN

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

COMPLETED

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

COMPLETED

Duke Cancer Center

Durham, North Carolina, 27710, United States

WITHDRAWN

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

WITHDRAWN

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

WITHDRAWN

University of Pittsburgh UPMC - Clinical Research Services

Pittsburgh, Pennsylvania, 15232, United States

COMPLETED

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75235, United States

WITHDRAWN

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, 21034, France

WITHDRAWN

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, Bretange, 35033, France

COMPLETED

Centre Francois Baclesse (CFB)

Caen, Normandy, 14076, France

COMPLETED

Institut Bergonie

Bordeaux, Nouvelle-Aquitaine, 33076, France

COMPLETED

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38043, France

COMPLETED

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

Montpellier, 34295, France

COMPLETED

National Cancer Center

Gyeonggi-do, Gyeonggi-do, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

The Catholic University Of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Haeundae Paik Hospital

Pusan, Gyeongsangnam-do, 48108, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seol St. Mary's Hospital

Seoul, 06591, South Korea

COMPLETED

Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 3080, South Korea

RECRUITING

Severance Hospital

Seoul, 3722, South Korea

RECRUITING

MeSH Terms

Conditions

Deafness, Autosomal Recessive 39; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 4, 2019
• Study Start: January 7, 2020
• Primary Completion (Estimated): April 22, 2032
• Study Completion (Estimated): April 22, 2032
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * has the legal authority to share the data, and * has ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (18); FR (6); KR (16)