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

Phase 2RecruitingNCT04077099

Regeneron Pharmaceuticals231 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

231

Conditions

NSCLC

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (40)

University of Alabama at Birmingham

Birmingham, Alabama, United States

WITHDRAWN

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

Orange, California, United States

COMPLETED

Georgetown University Medical Center

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

COMPLETED

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States

Outcomes

Primary Outcomes

Number of patients with Dose Limiting Toxicities (DLTs)

Phase 1/Dose escalation

Time frame: Up to 21 days

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

Phase 1/Dose escalation