NCT04829604进行中（未招募）2 期
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Ambrx, Inc.
- 入组人数
- 72
- 试验地点
- 33
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
详细描述
A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and older
- •Life expectancy ≥ 6 months
- •Unresectable or metastatic breast cancer subjects
- •Presence of at least one measurable lesion per RECIST v 1.1
- •Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report
- •Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy in the metastatic setting. One of these prior treatments must have been treatment with T-DXd.
- •Subjects with stable brain metastases
- •Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement.
- •Adequate organ functions
- •Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol
排除标准
- •Any subject who meets any of the following criteria is excluded from the study:
- •History of allergic reactions to any component of ARX
- •Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.
- •Any active ocular infections or chronic corneal disorders
- •History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
- •Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
- •History of unstable central nervous system (CNS) metastases
- •Radiotherapy outside of the brain administered < 7 days prior to first dose of ARX788
- •Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)
- •Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments
- •Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788
研究组 & 干预措施
ARX788
Experimental
The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
干预措施: ARX788 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 2 years
To evaluate the confirmed objective response rate (ORR) as determined by Investigator assessment based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) following treatment with ARX788. The ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.
次要结局
- Disease control rate (DCR)(2 years)
- Maximum serum concentration (Cmax) for ARX788(Cycle 1 and cycle 3)
- Duration of response (DOR)(2 years)
- Best overall response (BOR)(2 years)
- Overall survival (OS)(2.5 years)
- Progression-free survival (PFS)(2 years)
- The number of subjects experiencing adverse event TEAEs(2 years)
- Trough concentration (Ctrough) for ARX788(Cycle 1 and cycle 3)
- Area under the serum concentration-time curve (AUC) for ARX788(Cycle 1 and cycle 3)
- Time to response (TTR)(Start of treatment to first objective confirmed BOR of CR or PR, assessed for approximately 2 years)
研究者
研究点 (33)
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Unknown
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