JPRN-jRCT2080225124已完成1 期
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of SCC244 in Japanese Patients with Advanced Solid Tumors
Shanghai Haihe Pharmaceutical Co., Ltd.0 个研究点目标入组 6 人开始时间: 2020年3月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1.Can fully understand and sign informed consent form (ICF) voluntarily
- •2.Male and female patients 18-80 (inclusive) on the day of signing informed consent. However, in case a subject is younger than 20 years old, written informed consent will be obtained from both a subject and a legal representative and the written informed consent will be re-obtained from the above subject when he or she will be 20 years old.
- •3.Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapies or for which there is no effective standard treatment.
- •4.At least one measurable or non-measurable lesion as per RECIST version1.1.
- •5.ECOG Performance Status (PS): 0-1.
- •6.Adequate bone marrow reserve, renal and liver function:
- •-Absolute neutrophil count >= 1.5x109/L;
- •-Hemoglobin >= 9 g/dL;
- •-Platelet count >= 75 x 109/L;
- •-Serum total bilirubin <= upper limit of normal (ULN);
- •-Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase <= 2.5 x ULN (<= 5 x ULN for patients with hepatic metastasis);
- •-Serum creatinine <= 1.5 x ULN, or creatinine clearance => 50 mL/min (calculated with Cockcroft-Gault formula).
- •-International normalized ratio (INR) <= 1.5 or activated partial thromboplastin time (aPTT) <= 1.5xULN.
排除标准
- •1.Patients who have already a confirmed negative test for MET mutation (tumor testing is not required for this study)
- •2.Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. 3.Patients neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for => 3 months at least two weeks prior to entering the study.)
- •4.Evidence of other malignancies (except for non-melanoma skin cancer, in situ breast cancer or in situ cervical carcinoma and superficial bladder cancer that have been effectively controlled in the last 5 years).
- •4.Patients' life expectancy < 3 months at the investigator's discretion.
- •5.Subjects with clinically significant cardiovascular disease, including:
- •-NYHA Class II or higher congestive heart failure:
- •-Severe arrhythmia requiring drug therapy;
- •-Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass graft received within 6 months prior to the first dose;
- •-Left ventricular ejection fraction (LVEF) < 50%;
- •-QTcF>450 ms (male) or QTcF>470 ms (female); or there are risk factors of torsade de pointes, such as clinically significant hypokalemia, family history of long QT syndrome or arrhythmia at the investigator's discretion (e.g. pre-excitation syndrome);
- •-Clinically uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure =>140 mmHg and/or diastolic blood pressure => 90 mmHg);
- •6.Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2prior platinum-therapy related neuropathy.
- •7.Active and clinically significant hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) infection.
- •The following patients will not be enrolled:
- •1)Confirmed HIV antibody positive.
- •2)Anti-HCV antibody positive and HCV-RNA positive. (In case of positive for Anti-HCV antibody, the patients with negative HCV-RNA can be enrolled.)
- •3)Patients with
- •-Hepatitis B surface antigent (HBsAg) positive, or
- •-Anti-Hepatitis B core antibody (HBcAb) positive, or
- •-Anti-Hepatitis B surface antibody (HBsAb) positive and HBV DNA positive. (In case of positive for anti-HBs antibody, the patients with negative HBV DNA can be enrolled.)
- •8.History of hypersensitivity to active or inactive excipients of SCC244 or drugs with a similar chemical structure or class to SCC244.
- •9.Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, or hormone therapy) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the investigational product.
- •10.Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- •11.Major surgery or had significant trau
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