NCT02221505终止1 期
A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incident rate of dose limiting toxicities (DLTs)
研究概览
简要总结
LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.
LOP628 provides an opportunity to target cKit overexpressing tumors.
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
- •For patients with solid tumors:
- •documented cKit-positive neoplasms
- •Patient must have progressive disease as defined by any of the following:
- •SCLC: patient has progressed after at least 1 prior therapy
- •GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists
- •Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
- •Patient has measurable disease as per RECIST v1.1 criteria
- •For patients with AML:
- •documented cKit-positive acute myelogenous leukemia
- •Consent to newly obtained bone marrow aspirate
- •Patient must have progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.
- •Blast count < 50,000/mm3
排除标准
- •For patients with solid tumors:
- •Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.
- •Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
- •Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
- •Patient has been previously treated with cKit directed antibodies
- •Pregnant or nursing women
- •For patients with AML:
- •Patient has received prior allogeneic bone marrow transplant (BMT).
- •Patient has the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease
- •Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
- •Patient has been previously treated with cKit directed antibodies
- •Pregnant or nursing women
研究组 & 干预措施
LOP628 - Solid Tumor
Experimental
with LOP628
干预措施: LOP628 (Drug)
LOP628 - AML
Experimental
With LOP628
干预措施: LOP628 (Drug)
LOP628 - Solid Tumor Expansion
Experimental
With LOP628
干预措施: LOP628 (Drug)
结局指标
主要结局
Incident rate of dose limiting toxicities (DLTs)
时间窗: Month 12
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
次要结局
- Best overall response (BOR)(30 months)
- Best Overall Response (AML)(30 months)
- Duration of response (DOR) (AML)(30 months)
- Event Free Survival (EFS) (AML)(30 months)
- Incidence of adverse events (AEs) and serious adverse events (SAE)(30 months)
- Severity of adverse events (AEs) and serious adverse events (SAEs)(30 months)
- Serum PK parameters (AUC, Cmax, Tmax, and half-life)(30 months)
- Serum concentration vs. time profiles(30 months)
- Overall response rate (ORR)(30 months)
- Duration of response (DOR)(30 months)
- Progression Free Survival (PFS)(30 months)
- Disease Control Rate (DCR) at 4 months(4 months)
研究者
研究点 (1)
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