ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Fudan University
Updated on 19 June 2022


A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).


This is an open-label, single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to TKI. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion. In this study, Simon's two-stage design is used. Subjects received treatment until disease progression, intolerable toxicity, withdrawal from the study, or discontinuation judged by the investigator. Drug efficacy and safety data will be collected.

Condition HER2-positive, Metastatic Breast Cancer
Treatment ARX788
Clinical Study IdentifierNCT05018702
SponsorFudan University
Last Modified on19 June 2022


Yes No Not Sure

Inclusion Criteria

Age ≥18 years, and ≤75 years, male or female
Eastern Cooperative Oncology Group (ECOG) performance status of 0~2
Breast cancer patients diagnosed as HR arbitrary/HER2-positive by pathological examination
Metastatic breast cancer subjects previously treated with trastuzumab, taxane and EGFR-TKI-containing regimens
MRI confirmed brain metastasis with at least one intracranial parenchymal untreated metastatic lesion
Mannitol, bevacizumab, or hormone therapy is allowed before enrollment
Adequate organ functions
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1
Patients who participate in the trial voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit

Exclusion Criteria

Pneumomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture
Uncontrolled third space effusion
Previous treatment with T-DM1 or other HER2-ADC drugs
Received a whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to the first dose of ARX788, or trastuzumab-targeted therapy or endocrine therapy within 1 week, or palliative radiotherapy for bone metastases within 2 weeks
Prior history of interstitial pulmonary disease requiring hormone therapy, drug-induced interstitial pulmonary disease, radiation pneumonia, or current clinically active interstitial pulmonary disease
Suffering from keratitis, corneal diseases, retinal diseases or active eye infections that require intervention
Unwilling or unable to stop wearing contact lenses for the duration of the study
Participated in other clinical trials within 2 weeks prior to enrollment
Receiving any antitumor therapy for any other tumor, bevacizumab for the control of brain edema and bisphosphonates for the treatment of bone metastases or the prevention of osteoporosis are the exception
With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin
Cardiac insufficiency
Uncontrolled hypertension
History of allergic reactions to any component of ARX788, or with a history of protein drug allergy, a history of specific allergies (asthma, rheumatism, eczematous dermatitis), or a history of other severe allergic reactions, who are unsuitable for ARX788 treatment as per the investigator's judgments
Pregnancy or lactation
History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus or syphilis
History of neurological or psychiatric disorder, including epilepsy or dementia
Suffering severe or uncontrolled systemic diseases
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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