NCT05263869Unknown2 期
An Open-label, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Advanced HER-2 Positive Breast Cancer Patients Previously Treated With Trastuzumab and TKIs (Magic-009)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR) by Independent Review Committee (IRC)
研究概览
简要总结
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2 positive breast cancer with liver metastases.
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 to sign the informed consent form and follow the requirements specified in the protocol.
- •Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
- •The score of ECOG for performance status is 0 or 1
- •Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
- •Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
- •Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
- •Organ functions must meet the basic requirements.
- •Patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug.
排除标准
- •Previous history of other primary malignancies;
- •Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
- •Previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, CYP3A4 inhibitors or inducers, anthracyclines and other treatments;
- •Central nervous system metastasis and/or neoplastic meningitis;
- •History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
- •Pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; Or pericardial effusion with combined clinical symptoms;
- •Any serious or uncontrolled systemic disease judged by the investigator;
- •Uncontrolled cardiac disease;
- •Evidence of active infection;
- •Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;
- •History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;
- •Patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment;
- •History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
- •Uncontrolled tumor-related bone pain or urgent spinal cord compression;
- •Other conditions inappropriate for participation in this study, as deemed by the investigator.
研究组 & 干预措施
MRG002
Experimental
MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).
干预措施: MRG002 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Independent Review Committee (IRC)
时间窗: Baseline to study completion (up to 12 months）
ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.
次要结局
- Duration of Response (DOR)(Baseline to study completion (up to 12 months))
- Objective Response Rate (ORR) by Investigator(Baseline to study completion (up to 12 months))
- Clinical Benefit Rate (CBR)(Baseline to study completion (up to 12 months))
- Time to Response (TTR)(Baseline to study completion (up to 12 months))
- Overall Survival (OS)(Baseline to study completion (up to 12 months))
- PK parameters: concentration-time curve(Baseline to 14 days after decision to discontinue treatment)
- Disease Control Rate (DCR)(Baseline to study completion (up to 12 months))
- Progression Free Survival (PFS)(Baseline to study completion (up to 12 months))
- Immunogenicity (ADA)(Baseline to 14 days after decision to discontinue treatment)
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
研究者
研究点 (2)
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