Study of REGN5093-M114 for Advanced Cancer with High MET Protein Levels

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04982224

Provider View

This clinical trial is testing a new drug, REGN5093-M114, alone and with another drug, cemiplimab, for advanced non-small cell lung cancer (NSCLC) that has high levels of a protein called MET. The study aims to find out if the drug is safe, tolerable, and effective in shrinking tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment called REGN5093-M114, which is being tested alone and in combination with cemiplimab. The focus is on advanced non-small cell lung cancer (NSCLC) that produces too much of a protein called MET. The study aims to determine the safety, tolerability, and effectiveness of the treatment. Participants will be divided into three groups, each with two parts. Part 1 will find a safe dose of the drug, and Part 2 will test how well it works to shrink tumors. Researchers will also look at potential side effects, how the drug affects cancer progression, how much of the drug is in the blood at different times, and if the body makes antibodies against the drug.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-small cell lung cancer (NSCLC) with no other approved treatments available.
  • Willing to provide a tumor sample from a recent biopsy. If a new biopsy is not possible, an older sample may be used if it meets specific conditions.
  • The cancer must show high levels of the MET protein.
  • For certain study groups, have at least one tumor that can be measured by scans, even if it was previously treated with radiation.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function as determined by specific medical tests.

Exclusion Criteria

  • Have received other cancer treatments or participated in another study within a short time before starting this study.
  • Have not fully recovered from side effects of previous treatments.
  • Have had recent radiation therapy or major surgery and not fully recovered.
  • Have another active cancer that needs treatment.
  • Have untreated or active brain tumors or other serious brain conditions.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C, or have a diagnosed immune deficiency.

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