NCT05473624招募中1 期
A Phase I, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 19
- 主要终点
- Dose-limiting toxicity (DLT) of HRS-1167
研究概览
简要总结
This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid 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
- •ECOG performance status 0-1;
- •Life expectancy is not less than 12 weeks;
- •Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists；
- •Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation；
- •At least one target lesion (except maintenance therapy);
- •Adequate organ and marrow function as defined by the protocol.
排除标准
- •Surgery or chemotherapy within 4 weeks of the first dose of study treatment；
- •Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption；
- •Active HBV/HCV/HIV infection;
- •Untreated and/or uncontrolled brain metastases.
研究组 & 干预措施
HRS-1167
Experimental
干预措施: HRS-1167 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT) of HRS-1167
时间窗: up to 24 days
AEs+SAEs
时间窗: up to 24 months
from the first drug administration to within 30 days for the last treatment dose
Maximum tolerated dose (MTD) of HRS-1167
时间窗: up to 24 months
Recommended Phase II Dose (RP2D) of HRS-1167
时间窗: up to 24 months
次要结局
- Evaluation of pharmacokinetic parameter of HRS-1167: AUC(At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days))
- Objective Response Rate (ORR)(up to 24 months)
- Evaluation of pharmacokinetic parameter of HRS-1167: Cmax(At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days))
- Evaluation of pharmacokinetic parameter of HRS-1167: Tmax(At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days))
- Disease control rate (DCR)(up to 24 months)
- Duration of response (DoR)(up to 24 months)
- Progression Free Survival (PFS)(up to 24 months)
研究者
研究点 (19)
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