A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens
Brief SummaryA 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
Detailed DescriptionA Global, Single Arm, 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. The ARX788 will be administered every 4 weeks (Q4W) intravenous (IV) infusion.
Inclusion and Exclusion 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
- 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 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.
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.