NCT05018676Unknown2 期
A Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of Unresectable and/or Metastatic Breast Cancer With Low Expression of HER2
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ARX788
Experimental
干预措施: ARX788 (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: 2 years
ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1
次要结局
- Duration of relief (DOR)(2 years)
- Overall survival (OS)(2 years)
- Disease control rate (DCR)(2 years)
- Progression-free survival (PFS)(2 years)
研究者
研究点 (1)
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