Phase I/II First-in-Human Study of TT-4 As a Single Agent in Participants with Advanced Selected Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 69
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.
详细描述
Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-4 in subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment.
The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-4 in subjects with advanced subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, antitumor activity, and efficacy of TT-4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
Multiple Ascending Dose
3+3 Dose escalation until MTD and/or R2PD of TT-4 is determined
干预措施: TT-4 (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase
时间窗: 28 Days
All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-4during the dose escalation phase
时间窗: Up to 1 year
次要结局
- Incidence of treatment-emergent adverse events (TEAEs) overall and by severity, seriousness and relatedness.(Through study completion, an average of 1 year)
- Duration of Response (DoR)(From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)])
- Progression Free Survival (PFS)(From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)])
- Peak serum concentration (Cmax) of TT-4(Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose)
- Area under the serum concentration versus time curve (AUC) of TT-4(Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose)
- Half-life of TT-4(Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose)