A Phase 1 Study of MGY825 in People with Lung Cancer

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Full Title

An Open-Label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients with Advanced Non-Small Cell Lung Cancer

Purpose

Researchers want to find the best dose of MGY825 to treat advanced non-small cell lung cancer (NSCLC). The people in this study have NSCLC that has metastasized (spread). The tumors also have a mutation (change or variant) in at least one of these genes: NFE2L2, KEAP1, and CUL3. When people have a mutation in these genes, their cancer cells can grow uncontrollably.

MGY825 blocks a specific enzyme (a protein that speeds up chemical reactions in the body), leading to cancer cell death. By blocking this enzyme, MGY825 may slow or stop cancer growth and shrink tumors. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic NSCLC that keeps growing even after chemotherapy and immunotherapy.
  • Have a mutation in one or more of these genes: NFE2L2, KEAP1, and CUL3.
  • Have completed chemotherapy at least 3 weeks before taking MGY825 and immunotherapy at least 4 weeks before.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Paul Paik’s office at 646-608-3759.

Protocol

22-425

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05275868