ARX788 in Breast Cancer With Low Expression of HER2

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer With Low Expression of HER2

Treatments

Drug: ARX788

Study type

Interventional

Funder types

Other

Identifiers

NCT05018676

ACE-Breast-07

Details and patient eligibility

About

A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.

Full description

A single arm, phase 2 study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2. Subjects should received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy). HER2 low expression is defined as HER2 IHC 1+ or HER2 IHC 2+ and FISH negative. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to understand and sign an informed consent inform;
Age ≥18 years, and ≤75 years, male or female;
Diagnosed as HR arbitrary/HER2 low expression unresectable and/or metastatic breast cancer. HER2 low expression is defined as HER2 IHC 1+ (FISH negative or FISH not done) or HER2 IHC 2+ and FISH negative;
Received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy);
Never had a HER2 positive result (IHC 3+ or FISH+) in previous pathological examinations;
Have archived or fresh tumor tissue samples for HER2 status confirmation;
According to the RECIST 1.1 standard, there is at least one measurable lesion;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1; LVEF≥50%;
Adequate organ functions;
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1;
Life expectancy ≥ 3 months.

Exclusion criteria

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;
Previous treatment with T-DM1 or other HER2-ADC drugs;
Have other malignant tumors within 5 years before signing the informed consent form (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated, except malignant tumors that are considered cured);
Have primary central nervous system (CNS) tumors or CNS metastases;
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;
Cardiac insufficiency;
Uncontrolled hypertension;
Suffering severe or uncontrolled systemic diseases;
Had chemotherapy, radiotherapy, or immunotherapy within 4 weeks before the first dose;
Had breast cancer endocrine therapy within 2 weeks before the first dose;
Had palliative radiotherapy for bone metastasis within 2 weeks before the first dose;
Any uncontrolled infection, or other conditions that may limit trial compliance or interfere with evaluation;
Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus or syphilis;
Plan to receive major surgical treatment within 2 weeks before first dose or during the trial period, or have suffered severe traumatic injury;
Pregnancy or lactation;
Unwilling or unable to use acceptable methods for contraception during the entire treatment period of this trial and within 8 months after the last dose;
Participated in other clinical trials and used other experimental drugs within 4 weeks before the first dose;
Any mental or cognitive impairment may limit their understanding and implementation of the informed consent form;
Not suitable for participating in this trial, such as poor compliance.