A Phase I Study of GNX102 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
GNX102 is a humanized monoclonal antibody (mAb), an engineered biotechnology product, developed by GlycoNex that targets certain cancer cells by binding with high affinity to specific structures on cancer cells. Specifically, GNX102 binds to novel glycan structures caused by glycosylation changes in tumors.
Patients with epithelial origin cancers that have a likelihood of GNX102 targeted antigen expression based on previous studies, including colorectal, hepatocellular, non-small cell lung, gastric, breast, pancreatic, cutaneous, acral, or mucosal melanoma, esophageal, prostate, and epithelial uterine cancers, can be screened for enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1 Dose Escalation
Drug: GNX102 Dose Escalation: 21 day dosing interval
干预措施: GNX102 (Drug)
Part 2 Dose Escalation
Drug: GNX102 Dose Escalation: 7 day dosing interval
干预措施: GNX102 (Drug)
Part 3 Expansion
Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s)
干预措施: GNX102 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Through study completion, an average of 2 years
If ≤ 1 of 6 patients has a dose limiting toxicity (DLT) after all previous dose testing the dose will be declared the Maximum Tolerable Dose (MTD).
次要结局
- Number of toxicities(Through study completion, an average of 2 years)
- Tmax: Time to maximum plasma concentration of GNX102 (minutes)(Through study completion, an average of 2 years)
- Vz: Apparent volume of distribution in the terminal phase of GNX102 (L)(Through study completion, an average of 2 years)
- Antitumor activity of GNX102(Through study completion, an average of 2 years)
- AUC: Area under the concentration curve of GNX102 (μg × h/mL)(Through study completion, an average of 2 years)
- Cmax: Maximum plasma concentration of GNX102 (μg)(Through study completion, an average of 2 years)
- t1/2: Terminal phase half-life of GNX102 (minutes)(Through study completion, an average of 2 years)
- Number of adverse events (AEs)(Through study completion, an average of 2 years)
- CL: Clearance of GNX102 (L/hr)(Through study completion, an average of 2 years)