A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors Who Have Failed Adequate Standard Treatments or Are Intolerant to Standard Therapies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax of HS-20093 and free toxin
研究概览
简要总结
The primary objective of this study is to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors.
详细描述
This is a multicenter, open-label, non-randomized, fixed-sequence, self-controlled clinical study designed to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors who have failed or are intolerant to standard therapy.
All participants will receive intravenous infusion of HS-20093 at a dose of 8 mg/kg every 3 weeks (Q3W), with each treatment cycle lasting 21 days. Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
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 advanced solid tumors that have failed standard therapy or are intolerant to standard treatment.
- •According to RECIST 1.1 criteria, participants must have at least one target lesion.
- •ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose.
- •Minimum expected survival greater than 12 weeks.
排除标准
- •Patients with a contraindication for receiving itraconazole according to the prescribing information
- •Patients with severe, uncontrolled, or active cardiovascular diseases
研究组 & 干预措施
HS-20093 + Itraconazole
干预措施: HS-20093 (Drug)
HS-20093 + Itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Cmax of HS-20093 and free toxin
时间窗: Three treatment cycles, each cycle lasting for three weeks.
Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
AUC0-16d of HS-20093 and free toxin
时间窗: Three treatment cycles, each cycle lasting for three weeks.
Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.
次要结局
- Tmax of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- t1/2 of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- AUC0-∞ and AUC0-tau of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- Cmin of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- CL of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- V of HS-20093 and free toxin(Three treatment cycles, each cycle lasting for three weeks.)
- Incidence and severity of adverse events (AEs)(Screening to 90 days post-last dose)