arx788 in breast cancer with low expression of her2

Conditions: Breast Cancer With Low Expression of HER2

Summary: a phase 2 study of arx788 in unresectable and/or metastatic breast cancer with low expression of her2.

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.

Eligibility criteria:
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.

Keywords: arx788 breast cancer low expression of her2