Triple Negative Breast Cancer Clinical Trial
Official title:
Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate) for Patients With HER2-low Locally Advanced Unresectable / Metastatic Breast Cancer
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.
PRIMARY OBJECTIVES: I. To evaluate the objective response rate (ORR) of participants with HER2-low locally advanced unresectable/metastatic breast cancer on ARX788 monotherapy. SECONDARY OBJECTIVES: I. To evaluate the efficacy of ARX788 monotherapy in participants with HER2-low locally advanced unresectable / metastatic breast cancer as measured by duration of response (DOR), best overall response (BOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). II. To evaluate the safety of ARX788 monotherapy in participants with HER2-low locally advanced unresectable / metastatic breast cancer (MBC). OUTLINE: EXPLORATORY OBJECTIVES: I. Biomarker analyses to evaluate association of efficacy measures with potential biomarkers (e.g., via assessment of circulating tumor deoxyribonucleic acid (ctDNA), single cell ribonucleic acid [RNA] sequencing, etc.). II. Patient-reported outcomes (PROs) of patients on ARX788 monotherapy. III. To determine the feasibility, tolerability, and efficacy of eye toxicity prevention strategy. OUTLINE: Participants receive ARX788 intravenously (IV) over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants also undergo computed tomography (CT), positron emission tomography (PET)/CT, and collection of blood samples throughout the study. After completion of study treatment, participants are followed up at 30 days and then every 3 months for 1 year. ;
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