First Human Study of BAY2927088 for Advanced Non-Small Cell Lung Cancer with EGFR and HER2 Mutations

Sponsor: Bayer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05099172

Provider View

This clinical trial is testing a new drug, BAY2927088, to see if it can safely and effectively treat advanced non-small cell lung cancer (NSCLC) in patients with specific genetic mutations in EGFR and HER2 proteins.

Patient Parameters

Program Overview

Researchers are exploring a new treatment for advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread to other parts of the body. This study focuses on patients whose cancer cells have mutations in the EGFR and HER2 proteins, which help cancer grow and spread. The drug BAY2927088 is designed to block these mutated proteins and potentially stop the cancer from spreading. The study aims to determine how safe BAY2927088 is, the highest dose patients can tolerate, and how well it works in shrinking tumors.

Description

This study is divided into four parts:

  1. Escalation Part: The goal is to find the highest safe dose of BAY2927088 that patients can take.
  2. Backfill Part: This part tests the safe doses found in the escalation part on more patients to find the best dose for future studies.
  3. Expansion Part: This part aims to confirm the best dose of BAY2927088 for further research.
  4. Extension Part: This part evaluates how well the selected dose works in treating the cancer.

Participants will take BAY2927088 in cycles of three weeks, either once or twice daily as a liquid or tablet, until their cancer worsens, they experience medical issues, choose to leave the study, or the study ends. They will have up to five visits per cycle for health checks, including blood and urine tests, scans to monitor cancer, and assessments of their overall and heart health. Researchers will also ask about any side effects experienced.

A serious side effect is one that leads to death, is life-threatening, requires hospitalization, causes disability, or is medically significant.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or has spread.
  • Cancer must have progressed after at least one previous treatment, or standard treatments are not available, suitable, or tolerated.
  • Have a tumor sample available for testing, ideally taken within the last six months.
  • Have measurable cancer that can be tracked with scans.
  • Have a confirmed mutation in EGFR and/or HER2 genes.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate blood cell counts and organ function as determined by specific tests.

Exclusion Criteria

  • Have taken an EGFR inhibitor within eight days before starting the study drug.
  • Have received other cancer treatments within 14 days before starting the study drug.
  • Have had radiation therapy within 14 days before starting the study drug.
  • Have received immunotherapy within 28 days before starting the study drug.
  • Have unresolved side effects from previous treatments, except for hair loss or skin changes.
  • Have a history of brain or spinal cord cancer, or untreated brain metastases.
  • Have serious heart conditions or abnormal heart rhythms.
  • Have active infections like HIV, Hepatitis B, or Hepatitis C, unless well-controlled.
  • Are taking medications that strongly affect the liver enzyme CYP3A4.

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