NCT01963715终止1 期
A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
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
- 20
- 试验地点
- 4
- 主要终点
- Number of participants with dose limiting toxicities
研究概览
简要总结
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •18 years old at time of consent
- •Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
- •EGFR-positive tumor expression
- •Adequate blood and organ function
- •Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
- •Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements
排除标准
- •Other anti-cancer treatment during the study
- •Symptomatic brain metastases
- •Other clinically significant disease as defined by the protocol
- •Chronic skin condition that requires prescribed oral or intravenous treatment
- •History of severe rash that required discontinuation of prior EGFR targeted therapy
- •Receiving therapeutic doses of warfarin or heparin for anti-coagulation
- •Known diagnosis of HIV or active viral hepatitis
- •Women who are pregnant or breast feeding
研究组 & 干预措施
EGFR+ Solid Tumor
Experimental
EGFR+ Solid Tumor
干预措施: IMGN289 (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities
时间窗: Up to 2 years
次要结局
- Number of participants with adverse events(Up to 2 years)
- Area under the plasma concentration versus time curve(Up to 2 years)
- Peak plasma concentration (Cmax) of IMGN289(Up to 2 years)
- Presence of Human Anti Human Antibody and Human Anti Drug Antibody(Up to 2 years)
- Tumor measurements per RECIST 1:1(Up to 2 years)
研究者
研究点 (4)
Loading locations...
相似试验
终止
1 期
Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple MyelomaMultiple MyelomaNCT05908396IGM Biosciences, Inc.4
进行中（未招募）
1 期
A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) CancerAdvanced Solid TumorsAdvanced or Metastatic Gastric CancerAdvanced or Metastatic Gastroesophageal Junction CancerNCT04492488Shanghai Miracogen Inc.129
招募中
1 期
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal CancerFallopian Tube CancerPrimary Peritoneal CancerOvarian CancerNCT05739981Imunon30
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular CarcinomaHepatocellular CarcinomaNCT05595473Rznomics, Inc.42
已完成
1 期
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT02674763ImmunoGen, Inc.62