NCT01119456已完成1 期
Phase 1 Study of the Anti-Ron Receptor Monoclonal Antibody IMC-RON8 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) of IMC-RON8
研究概览
简要总结
A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •The participant has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available
- •The participant has measurable or non-measurable disease
- •The participant has not received major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy within 28 days prior to the first dose of study therapy
- •The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
- •The participant has adequate hematologic function
- •The participant has adequate renal function as defined by serum creatinine ≤1.5 times the institutional upper limit of normal (ULN)
- •The participant has a life expectancy >3 months
排除标准
- •The participant has received chemotherapy or therapeutic radiation therapy within 28 days prior to the first dose of study therapy
- •The participant has ongoing toxicities of >Grade 1 associated with any prior treatment
- •The participant has a known sensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-RON8
- •The participant has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
- •The participant has received treatment with agents specifically targeting the RON ligand or receptor within 6 weeks prior to first dose of study therapy
- •The participant has undergone a major surgical procedure, open biopsy, or experienced a significant traumatic injury within 28 days prior to the first dose of study therapy
- •The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding, or any other serious uncontrolled medical disorders in the opinion of the investigator
- •The participant has known or suspected brain or leptomeningeal metastases (participants with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and may not be taking steroids; participants receiving anticonvulsants are eligible)
- •The participant has a serious or nonhealing active wound, ulcer, or bone fracture
- •The participant is currently using or has received a thrombolytic agent within 28 days prior to first dose of study therapy
- •The participant is receiving full-dose warfarin (participants receiving low-dose warfarin to maintain the patency of permanent, indwelling intravenous catheters are eligible if the international normalized ratio is <1.5)
- •The participant is receiving intravenous heparin
研究组 & 干预措施
IMC-RON8
Experimental
A monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8).
干预措施: IMC-RON8 (Biological)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of IMC-RON8
时间窗: Baseline through end of study treatment (up to 48 weeks)
The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).
次要结局
- Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)(Baseline to measured PD (up to 48 weeks))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8(First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose)
- PK: Area Under the Curve (AUC) of IMC-RON8(First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose)
- Immunogenicity of IMC-RON8(Prior to first infusion through study completion (up to 52 weeks))
- Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8)(Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks))
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain MetastasesBrain MetastasesNCT02215512EpicentRx, Inc.29
已完成
1 期
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic RetinopathyDiabetic Macular EdemaDiabetic RetinopathyNCT00401115Santen Inc.50
已完成
1 期
Monoclonal Antibody Treatment for Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT00046774National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)23
撤回
1 期
Safety Study of Anti-Programmed Death-Ligand 1 in Hematologic MalignancyNon-Hodgkin's LymphomaMultiple MyelomaHodgkin LymphomaChronic Myelogenous LeukemiaNCT01452334Bristol-Myers Squibb
已完成
1 期
Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 ChannelCancerNCT01578564Soricimed Biopharma Inc23