A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 75
- 试验地点
- 5
- 主要终点
- The severity and the number of adverse events related to escalating doses of the MM-302.
研究概览
简要总结
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Locally advanced/unresectable or metastatic breast cancer
- •Eighteen years of age or above
- •Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- •Measurable disease according to RECIST v1.1
- •ECOG Performance Score of 0 or 1
- •Adequate bone marrow, hepatic, renal and cardiac function
- •Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-302
排除标准
- •Patients for whom potentially curative anticancer therapy is available
- •Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- •Symptomatic CNS disease
- •Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- •Received other recent antitumor therapy
- •Pregnant or breast feeding
- •Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
研究组 & 干预措施
MM-302
干预措施: MM-302 Monotherapy (Drug)
MM-302 in Combination with Trastuzumab
干预措施: MM-302 in combination with trastuzumab (Drug)
MM-302 in Combination with Trastuzumab q3w
干预措施: MM-302 in combination with trastuzumab q3w (Drug)
MM-302 in Combination with Trastuzumab and Cyclophosphamide
干预措施: MM-302 in combination with trastuzumab and cyclophosphamide (Drug)
结局指标
主要结局
The severity and the number of adverse events related to escalating doses of the MM-302.
时间窗: 12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
时间窗: 12 months
次要结局
- The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax(12 months)
- Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not(12 months)
- Objective response rate of MM-302(12 months)