Study on ARX788 for Patients with HER2-positive Metastatic Breast Cancer Previously Treated with T-DXd

Sponsor: Ambrx, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04829604

Provider View

This clinical trial is testing the drug ARX788 in patients with HER2-positive metastatic breast cancer who have already received treatment with T-DXd. The study aims to evaluate the effectiveness and safety of ARX788 when given every three weeks through an IV infusion.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment, ARX788, for patients with HER2-positive metastatic breast cancer who have previously been treated with T-DXd. The study will involve giving ARX788 through an IV infusion every three weeks to see how well it works and how safe it is for patients.

Description

This global Phase 2 study is focused on patients with HER2-positive metastatic breast cancer who have already been treated with T-DXd. Participants will receive ARX788 through an intravenous (IV) infusion every three weeks. The study aims to assess the drug's effectiveness in controlling cancer and its safety profile. Researchers will monitor participants for any side effects and measure the response of the cancer to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a life expectancy of at least 6 months.
  • Have breast cancer that cannot be surgically removed or has spread to other parts of the body.
  • Have at least one tumor that can be measured by scans.
  • Must provide a tumor sample to confirm HER2 status.
  • Have received no more than 5 previous treatments for metastatic cancer, including T-DXd.
  • Can have stable brain metastases.
  • Any side effects from previous treatments must have improved to a mild level, except for hair loss.
  • Must have good organ function.
  • Must be willing to understand and sign a consent form and follow the study procedures.

Exclusion Criteria

  • Have a history of allergic reactions to ARX788.
  • Have had lung diseases like interstitial lung disease or pneumonitis.
  • Have active eye infections or chronic corneal disorders.
  • Have had heart failure or unstable heart conditions in the past year.
  • Have severe nerve damage, although mild nerve damage may be allowed.
  • Have unstable cancer spread to the brain.
  • Have severe, uncontrolled diseases affecting the heart, lungs, or metabolism.
  • Have any serious illness or infection that could interfere with the study.
  • Have taken other cancer treatments within 14 days before starting ARX788.

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