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


Brief Summary

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

Primary Purpose
Study Type
Phase II


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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:

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 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 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0). Patients with Grade 2 neuropathy can be enrolled at investigator's discretion.
  • 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.

Join this Trial

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Study Stats
Protocol No.
Monica Rocha
  • TRIO-US - Hollywood FL
  • TRIO-US - Orlando FL
  • TRIO-US - Redondo Beach
  • TRIO-US - Sylmar
For Providers
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