NCT05537987进行中（未招募）1 期
A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
InnoCare Pharma Inc.3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
研究概览
简要总结
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
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
- •Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
- •Male or female patients with age ≥18 years old and ≤80 years old.
- •Measurable lesion according to RECIST 1.
- •Adequate organ functions that meet protocol requirement criteria.
- •Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
- •Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.
排除标准
- •Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
- •Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
- •Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
- •Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
- •Has evidence of uncontrolled heart disease
- •At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
- •Other conditions considered by the investigator to be inappropriate for participation in this study.
研究组 & 干预措施
ICP-723
Experimental
干预措施: ICP-723 (Drug)
结局指标
主要结局
Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
时间窗: through study completion, an average of 1.5 years.
次要结局
- Objective response rate (ORR) determined using RECIST 1.1 criteria.(Through study completion, an average of 4 years)
- Half-life (t1/2)(Through study completion, an average of 4 years)
- Apparent volume of distribution (Vz/F),(Through study completion, an average of 4 years)
- Disease control rate (DCR) determined using RECIST 1.1 criteria.(Through study completion, an average of 4 years)
- Apparent clearance (CL/F)(Through study completion, an average of 4 years)
- Peak concentration (Cmax)(Through study completion, an average of 4 years)
- Time to reach peak concentration (Tmax)(Through study completion, an average of 4 years)
- Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t)(Through study completion, an average of 4 years)
研究者
研究点 (3)
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