This study is in progress, not accepting new patients

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

a study on Non-Small Cell Lung Cancer Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around

Description

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

Official Title

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Keywords

NSCLC, MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease, Autosomal Recessive 39 Deafness, Non-Small-Cell Lung Carcinoma, Neoplasm Metastasis, REGN5093

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

  • University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
    Orange California 92868 United States
  • The University of Texas MD Anderson Cancer Center
    Houston Texas 77030 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04077099
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 95 people participating
Last Updated