NCT05245058招募中早期 1 期
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive 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 of 0 to
- •Life expectancy of more than 3 months.
- •At least one measurable lesion exists.(RECIST 1.1)
- •Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min
- •Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class
- •Blood pregnancy test was negative within 3 days prior to first dose.
排除标准
- •Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
- •Known active infection within 2 weeks prior to baseline.
- •Subjects with third space fluid that can not be controled.
- •Subjects with uncontrolled or severe cardiovascular disease.
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- •Subjects with severe lung disease.
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- •Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
- •Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
- •Uncured other tumors within 5 years.
- •Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
- •Evidence of chronic active hepatitis B or C
- •Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
- •Receive any live or attenuated live vaccine within 28 days prior to baseline.
- •Evidence of severe allergies.
- •Evidence of alcohol or drug abuse.
- •Evidence of neurological or psychiatric disorders.
研究组 & 干预措施
SPH5030 tablets
Experimental
Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day.
Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.
干预措施: SPH5030 tablets (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 24 days
Measurement of DLT of SPH5030 in all subjects
Maximum tolerated dose（MTD）
时间窗: Up to 24 days
Measurement of MTD of SPH5030 in all subjects
Number of patients with adverse events
时间窗: Up to 2 years
Adverse event type, incidence, duration, correlation with study drug
次要结局
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030(Up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030(Up to 2 years)
- Objective Response Rate (Investigator)(Up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030(Up to 2 years)
- Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030(Up to 2 years)
- Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030(Up to 2 years)
- Total clearance(CL) of SPH5030(Up to 2 years)
- Maximum serum concentration (Cmax) of SPH 5030(Up to 2 years)
- Time of maximum serum concentration (Tmax) SPH 5030(Up to 2 years)
- Half-life (t1/2) of SPH5030(Up to 2 years)
- Terminal rate constant(λz) of SPH5030(Up to 2 years)
- Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030(Up to 2 years)
- Volume of distribution(Vz) of SPH5030(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of remission (DOR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- 6-month Progression-free Survival (6mPFS)(Up to 2 years)
研究者
研究点 (17)
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