Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Laura Huppert
Headshot of Laura Huppert
Laura Huppert

Description

Summary

This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.

Official Title

Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

Details

Keywords

HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Antibody-drug Conjugate, Carcinoma, Breast Neoplasms, Triple Negative Breast Neoplasms, Amiloride, Immunoconjugates, ARX788, Computed Tomography (CT), Biospecimen Collection, HR+/HER2-low, HR-/HER2-low, Ocular Toxicity Prevention Sub-study

Eligibility

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Laura Huppert
    Dr. Laura Huppert is an oncologist who cares for patients with all stages of breast cancer. Huppert's research focuses on designing and conducting clinical trials to evaluate new cancer treatments, including ways to combine therapies so as to improve outcomes.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Laura Huppert, MD, BA
ID
NCT06224673
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated