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

NCT04077099 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 1/2

Started

2020-01-07

Last updated

2026-09-16

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

REGN5093

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

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of patients with Dose Limiting Toxicities (DLTs) — Up to 21 days
Phase 1/Dose escalation
Incidence and severity of treatment-emergent adverse events (TEAEs) — Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of adverse events of special interest (AESIs) — Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of serious adverse events (SAEs) — Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities — Through study completion, an average of 12 years
Phase 1/Dose escalation
REGN5093 concentrations in serum over time — Through study completion, an average of 12 years
Phase 1/Dose escalation
Objective response rate (ORR) per RECIST 1.1 — Through study completion, an average of 12 years
Phase 2/Dose expansion

Trial sites (29)

Facility	City	Region
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241	Orange	California
Georgetown University Medical Center	Washington D.C.	District of Columbia
Moffitt Cancer Center - McKinley Drive	Tampa	Florida
Dana Farber Harvard Cancer Center Consortium	Boston	Massachusetts
Icahn School of Medicine at Mount Sinai	New York	New York
Memorial Sloan Kettering Cancer Center	New York	New York
University of Pittsburgh UPMC - Clinical Research Services	Pittsburgh	Pennsylvania
The University of Texas MD Anderson Cancer Center	Houston	Texas
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou	Rennes	Bretange
Institut Bergonie	Bordeaux	New Aquitaine
Centre Francois Baclesse (CFB)	Caen	Normandy
Centre Hospitalier Universitaire de Grenoble	Grenoble	France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve	Montpellier	France
National Cancer Center	Gyeonggi-do	Gyeonggi-do
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
The Catholic University Of Korea St. Vincent's Hospital	Suwon	Gyeonggi-do
Ajou University Hospital	Suwon	Gyeonggi-do
Haeundae Paik Hospital	Pusan	Gyeongsangnam-do
Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do
Gachon University Gil Medical Center	Incheon	Namdong-gu
Chungbuk National University Hospital	Cheongju-si	North Chungcheong
Pusan National University Hospital	Busan	South Korea
Severance Hospital Yonsei University Health System	Seoul	South Korea
Asan Medical Center	Seoul	South Korea
Samsung Medical Center	Seoul	South Korea
Seol St. Mary's Hospital	Seoul	South Korea
Boramae Medical Center	Seoul	South Korea
Korea University Guro Hospital	Seoul	South Korea
Seoul National University Hospital	Seoul	South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04077099 on ClinicalTrials.gov ↗ ← All trials in the USA