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ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05018702
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : June 1, 2022
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment Phase
HER2-positive, Metastatic Breast Cancer Drug: ARX788 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of HER2-positive Breast Cancer Patients With Brain Metastases
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: ARX788 Drug: ARX788
1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle.

Primary Outcome Measures :
  1. Central nervous system (CNS) clinical benefit rate (CBR) [ Time Frame: 2 years ]
    CNS CBR is defined as the percentage of subjects who have achieved complete response, partial response, and stable disease according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 2 years ]
    PFS is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable subjects. Subjects will be censored at time of subsequent therapy

  2. Overall survival (OS) [ Time Frame: 2 years ]
    Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause). Subjects who are alive will be censored at the last known time that the subject was alive

  3. Site of first progression [ Time Frame: 2 years ]
    Record the organs where the disease first progressed during the study

  4. The number of subjects experiencing adverse events [ Time Frame: 2 years ]
    Patient safety and adverse events (AEs) will be evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05018702

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Contact: Ting Li 86-18121299346

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Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Ting Li, M.D., Ph.D.    86-18121299346   
Sponsors and Collaborators
Fudan University
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Responsible Party: Xichun Hu, Professor, Fudan University Identifier: NCT05018702    
Other Study ID Numbers: ACE-Breast-06
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xichun Hu, Fudan University:
HER2-positive breast cancer
Brain metastasis
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases