A Global, Phase II Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Study Identifier:
ACE-Breast-03
CT.gov Identifier:
NCT04829604
EudraCT Identifier:
2021-001246-36
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

To assess anticancer activity and safety of ARX788 in HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.

Efficacy will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 via imaging every 8 weeks (+7 days) on study.

To assess anticancer activity and safety of ARX788 in patients with metastatic HER2 positive breast cancer.

Efficacy will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by imaging every 6 weeks on study. Endpoints include objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), best overall response (BOR), duration of response (DOR), and time to response (TTR). The safety and tolerability profile will be evaluated.

Potential predictive and/or prognostic biomarkers at baseline and on-treatment will be analyzed for exploratory purposes.

Descriptive statistics will be used to evaluate anticancer activity, safety, and tolerability

Efficacy will be assessed using RECIST v1.1 at nine-week

intervals after starting ARX788 until progression or start of new cancer treatment.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18 - 59 Years
    Study Drug
  • Drug: Experimental: ARX788
    • Read More
  • Drug: The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
  • Drug: Intervention:
  • Drug: SABCS 2021:
  • Drug: SABCS 2022:
  • Drug: Patients will be administered 1.5 mg/kg of ARX788 every three weeks.
  • Drug: ASCO 2024
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Age ≥ 18 years and older
    • Life expectancy ≥ 6 months
    • Unresectable or metastatic breast cancer subjects
    • Presence of at least one measurable lesion per RECIST v 1.1
    • Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report
    • Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy in the metastatic setting. One of these prior treatments must have been treatment with T-DXd.
    • 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, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement.
    • Adequate organ functions
    • Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol
    Exclusion criteria
    • Any subject who meets any of the following criteria is excluded from the study:
    • History of allergic reactions to any component of ARX788.
    • Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.
    • Any active ocular infections or chronic corneal disorders
    • History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
    • Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
    • History of unstable central nervous system (CNS) metastases
    • Radiotherapy outside of the brain administered < 7 days prior to first dose of ARX788
    • 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers