ARX788 for Treating Patients with HER2-low Advanced or Metastatic Breast Cancer

Sponsor: Laura Huppert, MD, BA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06224673

Provider View

This phase II clinical trial is exploring how well a new drug, ARX788, works for patients with HER2-low breast cancer that is advanced or has spread to other parts of the body. ARX788 is a special type of treatment that combines an antibody with a toxin to target and kill cancer cells.

Patient Parameters

Program Overview

The study aims to find out if ARX788, an antibody-drug conjugate, is effective and safe for treating patients with HER2-low breast cancer that cannot be surgically removed or has spread. ARX788 is given through an IV infusion and works by attaching to a protein called HER2 on cancer cells, delivering a toxin to kill them. Researchers hope this treatment will help control the cancer in patients with this specific type of breast cancer.

Description

The main goal of this study is to see how well ARX788 can shrink tumors in patients with HER2-low advanced or metastatic breast cancer. Researchers will also look at how long the treatment works, how safe it is, and how it affects patients' quality of life.

Participants will receive ARX788 through an IV infusion every 21 days, as long as the cancer does not get worse or side effects are manageable. The study will also test a special eye drop to prevent eye side effects in some participants.

After finishing the treatment, participants will have follow-up visits to monitor their health and the effects of the treatment. The study will also collect information on how the drug moves through the body and its effects on cancer-related markers.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who can provide informed consent.
  • Have a specific type of breast cancer called HER2-low that is advanced or has spread.
  • Have a good overall health status with an ECOG score of 0-2.
  • Have a life expectancy of at least 6 months.
  • Have at least one tumor that can be measured.
  • Have previously received at least one chemotherapy or similar treatment for advanced cancer.
  • Have stable and treated brain metastases, if present.
  • Meet specific blood and organ function criteria.
  • Agree to use effective birth control during and after the study.
  • HIV-positive individuals on effective treatment with undetectable viral load are eligible.
  • Individuals with controlled hepatitis B or C are eligible.

Exclusion Criteria

  • Previous treatment with ARX788 or similar drugs.
  • Allergic reaction to any part of ARX788.
  • Recent treatment with other cancer therapies.
  • Significant lung or eye conditions.
  • Recent heart problems or certain heart conditions.
  • Active infections or other serious health issues.
  • Pregnant or breastfeeding women.
  • Uncontrolled hepatitis B, C, or HIV infections.

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