A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
研究概览
简要总结
This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.
详细描述
The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.
PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.
This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.
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
- •Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
- •Male or non-pregnant, non-lactating female subjects age ≥18 years.
- •ECOG Performance Status 0~
- •Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
- •Life expectancy of >3 months, in the opinion of the Investigator.
- •Able to take oral medications and willing to record daily adherence to investigational product.
- •Adequate hematologic parameters unless clearly due to the disease under study.
- •Adequate renal and hepatic function
- •Able to understand and willing to sign a written informed consent form.
排除标准
- •History of another malignancy
- •Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
- •Significant cardiovascular disease
- •Known active HBV, HCV, AIDS-related illness.
- •Has received a live vaccine within 30 days
- •History of active autoimmune disorders or ongoing immunosuppressive therapy.
- •Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
- •Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.
研究组 & 干预措施
Monotherapy Escalation
3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.
干预措施: PRJ1-3024 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
时间窗: Day 1 to Day 21
Safety listings and pharmacokinetic listings will be used for evaluation
次要结局
- Incidence of adverse events (AEs)(24 months)
- Duration of response (DOR)(24 months)
- Pharmacokinetic parameter：Maximum observed concentration (Cmax)(24 months)
- Pharmacokinetic parameter：AUC（0-last）(24 months)
- Pharmacokinetic parameter： Accumulation ratio(24 months)
- Objective response rate (ORR)(24 months)