Phase 1/2 Study on the Safety and Effectiveness of YH42946 for Advanced Solid Tumors with HER2 and EGFR Mutations

Sponsor: Yuhan Corporation

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06616766

Provider View

This clinical trial is testing a new oral medication, YH42946, to see if it is safe and effective in treating patients with advanced solid tumors that have specific genetic changes in HER2 and EGFR. The study will determine the best dose and assess the drug's ability to fight cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of a new drug called YH42946 in patients with advanced solid tumors that have specific genetic changes in HER2 and EGFR. The study is divided into two parts: the first part will find the highest safe dose, and the second part will test the effectiveness of the drug at selected doses. Participants will be grouped into different cohorts based on their specific cancer characteristics.

Description

YH42946 is a new type of drug taken by mouth that targets specific changes in the HER2 gene. It has shown promise in treating various HER2-related changes, including overexpression, amplification, or mutation, as well as changes in the EGFR gene.

This study is the first time YH42946 is being tested in humans and is conducted in multiple centers. It consists of two parts:

  • The first part involves gradually increasing the dose to find the maximum dose that patients can tolerate.
  • The second part involves testing the drug at selected doses to determine its effectiveness in treating cancer.

Several groups of patients will be included in the study, each with specific cancer characteristics.

Eligibility Criteria

Inclusion Criteria

  • Must be in good overall health with a performance status of 0 or 1.
  • Expected to live at least 3 more months.
  • Cancer has worsened after all standard treatments or standard treatments are not suitable.
  • Must provide a tumor sample to confirm HER2 or EGFR mutations.
  • If there is a history of brain metastases, all lesions must have been treated.
  • Must have adequate organ function, including:
    • Sufficient bone marrow function without recent use of growth factors or blood transfusions.
    • Proper liver function with specific limits on liver enzymes and bilirubin levels.
    • Proper kidney function with specific limits on creatinine levels or estimated filtration rate.

[For Dose Escalation Part Only]

  • Must have a confirmed diagnosis of advanced or metastatic non-blood cancer.
  • Must have documented HER2 or EGFR mutations.

[For Dose Expansion Part Only]

  • Must have confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion.

Exclusion Criteria

  • Have active or worsening brain metastases.
  • Have known or suspected cancer spread to the brain or spinal cord lining.
  • Have uncontrolled spinal cord compression.
  • Have had recent severe heart problems, including heart attacks or surgeries within the past 24 weeks.
  • Have a history of severe heart failure.
  • Have medical or mental conditions that prevent understanding the study or following the protocol.
  • Have severe concurrent diseases or conditions that make participation inappropriate.
  • Have a history of lung disease requiring steroids or current lung disease.
  • Have a history of another primary cancer, except for certain treated skin, cervical, or breast cancers, or other cancers with no active disease for the last 2 years.
  • Have HIV or active hepatitis B or C infections.
  • Have had major surgery within 4 weeks before starting the study treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.