NCT01969643已完成1 期
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 290
- 试验地点
- 38
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
- •One of the following:
- •Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
- •Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
- •Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
- •Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
- •Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
- •Part F: All of the following:
- •Triple negative breast cancer
- •No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
- •Tumor tissue PD-L1 expression CPS <10 expression
- •Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
- •Parts E and F: Archival or fresh baseline tumor sample is required.
- •Measurable disease
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Combination Arm: adequate heart function
排除标准
- •Pre-existing neuropathy Grade 2 or higher
- •Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Parts E and F: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
- •Prior treatment with LV or prior treatment with an MMAE-containing therapy
- •Combination Arm: hypersensitivity to trastuzumab
研究组 & 干预措施
LV + Trastuzumab
Experimental
干预措施: Trastuzumab (Drug)
LV Dose Escalation
Experimental
干预措施: ladiratuzumab vedotin (Drug)
LV + Trastuzumab
Experimental
干预措施: ladiratuzumab vedotin (Drug)
LV Monotherapy
Experimental
LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).
干预措施: ladiratuzumab vedotin (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through 1 month following last dose; up to approximately 2 years
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities
时间窗: Through 1 month following last dose; up to approximately 2 years
To be summarized using descriptive statistics.
Incidence of dose-limiting toxicity (DLT)
时间窗: Through 3 weeks after first dose
次要结局
- Objective response rate (ORR)(Through 1 month following last dose; up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 8 years)
- PFS relative to prior therapy(Up to approximately 8 years)
- Blood concentrations of LV and metabolites(Through 3 weeks after dosing; up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 3 years)
- Incidence of antitherapeutic antibodies(Through 1 month following last dose; up to approximately 2 years)
- Overall survival (OS)(Up to approximately 8 years)
研究者
研究点 (38)
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