NCT05088070已完成1 期
Phase I Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors with C-Met Abnormalities
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3 + 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.
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
- •Patients with advanced solid tumors with c-Met abnormalities who have failed standard of care or are not eligible for standard therapy currently
- •ECOG score of 0 or
- •Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1 criteria.
- •Expected survival > 12 weeks.
- •Patients must have adequate organ function
- •Patients must give informed consent to the study and sign the informed consent form prior to the trial.
排除标准
- •Received anti-tumor therapies, including but not limited to chemotherapy, biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the first dose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to the start of study drug.
- •Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the first dose.
- •Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrow therapeutic windows within 2 weeks prior to the start of study drug.
- •Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) or hepatitis C (HCV).
- •Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 or having ≥Grade 2 peripheral neuropathy, except for alopecia and other events judged as tolerable by the investigator.
- •Known allergy to any component of the reference drug.
- •Known drug or alcohol dependence.
- •Received surgical treatment including surgical and interventional procedures within 4 weeks prior to the start of study drug.
- •Patients with brain metastases.
- •Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or evidence of any clinically active interstitial lung disease.
- •Acute bacterial, viral, or fungal infection requiring systemic therapy or unexplained fever (temperature > 38.5 °C) during screening, prior to the first dose.
- •Neurological and psychiatric patients with obvious poor compliance.
- •Any of the following within 6 months prior to signing of informed consent form: uncontrolled congestive cardiac failure, severe or unstable angina pectoris, myocardial infarction, stroke, coronary/peripheral artery bypass surgery, pulmonary embolism.
- •Arrhythmia uncontrolled by medication or sustained QTcB prolongation.
- •Hypertension uncontrolled by medication
- •Participated in other drug clinical studies within 28 days prior to the first dose of study drug.
- •Women who are pregnant or in lactation period or women/men with childbearing plans.
- •Patients who cannot take oral medication, or have previous surgical history or serious gastrointestinal diseases such as dysphagia, active gastric ulcer, which may impair the absorption of the study drug in the investigator's opinion.
- •Other prior or current concomitant malignancies.
- •Patients who are ineligible to participate in this trial for any reason judged by the investigator.
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 24 days
Measurement of MTD in all subjects.
Dose-limiting toxicity (DLT)
时间窗: 24 days
Incidence of DLT in all subjects.
次要结局
- Maximum serum concentration (Cmax) of SPH 3348.(24 days)
- Time of maximum serum concentration (Tmax) SPH 3348.(24 days)
- Area under the concentration-time curve (AUC) of SPH 3348.(24 days)
- Half-life (t1/2) of SPH 3348.(24 days)
- Progression-free survival (PFS)(24 days)
- Duration of remission (DOR)(24 days)
- Objective Response Rate (ORR)(24 days)
- Disease control rate (DCR)(24 days)
- Biomarker expression level(24 days)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple MyelomaRefractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaMultiple MyelomaNCT03201250University of Nebraska11
已完成
1 期
Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid TumorsAdvanced Solid TumorsNCT05905614Shanghai Pharmaceuticals Holding Co., Ltd29
已完成
1 期
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsHead and Neck Squamous Cell CarcinomaEndometrial CancerBreast CancerLung CancerMelanomaCRCUrothelial CarcinomaCholangiocarcinomaNCT03665285NextCure, Inc.109
已完成
1 期
A Study of ARRY-334543 in Patients With Advanced CancerAdvanced CancerNCT00637702Array Biopharma, now a wholly owned subsidiary of Pfizer31
已完成
1 期
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)Advanced or Metastatic HCCNCT00746317Chugai Pharmaceutical27