ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) (ACE-Breast03)

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens

  • Clinical Trial Information

    Trial Contact: Durand, Jennifer; Porter, Janice (Melinda)

    Trial Phone: 321.843.2026 ; 321.841.1077

  • IRB No: W21.142.09

    Protocol Abbrev: TRIO ACE-Breast-03

    Principal Investigator: Nikita Chandrakant Shah, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Treatment: The investigational medicinal product (IMP), ARX788, will be administered every 4 weeks (Q4W) by intravenous (IV) infusion.

    Therapies Involved: Medication ID: NCT04829604

  • Objective

    The confirmed objective response rate (ORR) of ARX788 based on RECIST 1.1 in HER2-positive breast cancer subjects whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.

  • Key Eligibility

    Inclusion Criteria:

    -Age ≥ 18 years and older
    -Life expectancy > 3 months
    -Eastern Cooperative Oncology Group Performance Status ≤ 1
    Metastatic breast cancer subjects previously treated with T DM1, and/or T-DXd, and/or tucatinib-containing regimens.
    -Presence of at least one measurable lesion per RECIST v 1.1
    -Subjects must have an adequate tumor sample available for confirmation of HER2 status
    -Subjects with stable brain metastases
    -Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia.
    -Adequate organ functions
    -Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol.
    -Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at postmenopausal, or who commits to use an acceptable form of birth control; male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control

    Exclusion Criteria:

    -History of allergic reactions to any component of ARX788.
    -Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months
    -History of ocular events, or any current ongoing active ocular infections.
    -History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia within 12 months prior to enrollment
    -Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 5.0)
    -History of unstable central nervous system (CNS) metastases
    -Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)
    -Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments.
    -Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.
    -Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788
    -Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.
    -Pregnancy or breast feeding.
    -Known active HCV, HBV, and/or HIV infection.