Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

Eli Lilly and Company6 个研究点分布在 1 个国家目标入组 72 人开始时间: 2011年6月最近更新: 2018年7月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 72
试验地点: 6
主要终点: Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.

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

•Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available
•Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
•Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•Subject has adequate hematologic, hepatic, renal, and coagulation function
•Subject has a life expectancy greater than 3 months
•Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy
•Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure

排除标准

•Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
•Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS
•Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
•Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment
•Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
•Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
•Subject has known or suspected primary brain or leptomeningeal metastases
•Subject has leukemia or lymphoma
•Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
•Subjects with known history, or clinical or laboratory evidence of liver disease
•Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
•Subject if female, is pregnant or breastfeeding
•Subject has received an organ transplant

研究组 & 干预措施

IMC-CS4 Weight Based Dosing

Experimental

Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A.

干预措施: IMC-CS4 (Biological)

IMC-CS4 Non-Weight Based Dosing

Experimental

Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B.

干预措施: IMC-CS4 (Biological)