ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

NCT05018702 | Unknown Phase 2

• 1 other identifier: ACE-Breast-06
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

HER2-positive, Metastatic Breast Cancer

Keywords

ARX788; HER2-positive breast cancer; Brain metastasis

Outcome Measures

Primary Outcomes (1)

• Central nervous system (CNS) clinical benefit rate (CBR)

  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

  2 years

Secondary Outcomes (4)

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Site of first progression

  2 years

• The number of subjects experiencing adverse events

  2 years

Study Arms (1)

ARX788

EXPERIMENTAL

Drug: ARX788

Interventions

ARX788 DRUG

1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle.

ARX788

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Related Publications (1)

• Li T, Lin M, Wang B, Zhao M, Cao J, Wang L, Tao Z, Jin J, Miao H, Gong C, Zhao Y, Peng W, Hu X, Zhang J. Efficacy and safety of ARX788 for individuals with HER2-positive breast cancer and brain metastases (ACE-Breast-06): a single-arm, phase 2 trial in China. EClinicalMedicine. 2025 Oct 30;90:103614. doi: 10.1016/j.eclinm.2025.103614. eCollection 2025 Dec.

  PMID: 41245540 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

ARX788

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ting Li

CONTACT

86-18121299346; cinderellaliting@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 24, 2021
• Study Start: July 14, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)