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.
Male or female participants age 18 years or greater with ability to provide written informed consent for the study.
Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Estimated life expectancy of at least at 6 months per investigator assessment.
Ability to understand and the willingness to sign a written informed consent document.
Has a prior history of treatment with ARX-788 or auristatin analogues.
Has a history of allergic reaction to any component of ARX788.
Has exposure to any other investigational or commercial anti-cancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of study treatment. NOTE: Anti-hormonal therapy may be administered up to 7 days prior to the first dose of study treatment.
Radiotherapy outside of the brain administered <7 days prior to first dose of ARX788
Laura Huppert, MD, BA
Lead sponsor
University of California, San Francisco
Sponsor institution
Ambrx, Inc.
Collaborator