Study on BH-30643 for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR and/or HER2 Mutations

Sponsor: BlossomHill Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06706076

Provider View

This clinical trial is testing a new drug, BH-30643, for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations. The study aims to find the best dose and evaluate the drug's effectiveness and safety.

Patient Parameters

Program Overview

The study is investigating a new treatment, BH-30643, for patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR or HER2 genes. The trial is divided into two phases. Phase 1 will determine the best dose for future studies, while Phase 2 will assess how well the drug works and its safety in patients with these genetic mutations. Participants will take BH-30643 capsules by mouth twice a day in 21-day cycles.

Description

BH-30643 is a new type of medication taken by mouth that targets specific mutations in the EGFR and HER2 genes, which are often found in non-small cell lung cancer (NSCLC). This study will test the safety and effectiveness of BH-30643 in patients with these mutations. The trial is open-label, meaning both the researchers and participants know what treatment is being given. It will take place at multiple centers and will involve two phases. Phase 1 will focus on finding the right dose, and Phase 2 will evaluate how well the drug works in shrinking tumors and its safety profile. Participants will take the medication in cycles, and their health and response to the treatment will be closely monitored.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR or HER2 mutations.
  • Have already received standard treatments for NSCLC.
  • Have at least one measurable tumor outside the brain.
  • 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 a life expectancy of at least 3 months.
  • Have adequate blood, liver, and kidney function.

Exclusion Criteria

  • Have had another type of cancer within the last 2 years.
  • Have other genetic changes that drive cancer growth or have had a change in cancer type.
  • Have unresolved side effects from previous treatments.
  • Have any significant and uncontrolled medical conditions, such as infections.
  • Have a history of lung disease from any cause.
  • Have had a major heart or organ-related event in the last 6 months.
  • Are currently participating in another clinical trial.

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