NCT04047771终止1 期
A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Subjects With Peritoneal Carcinomatosis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
To evaluate the safety and tolerability of SCB-313 in patients with peritoneal carcinomatosisa, to determine the maximum tolerated dose (MTD) and/or extended study recommended dose (RDE) for SCB-313 intraperitoneal injection, providing a basis for dosing regimen and dose choosing in clinical trial subsequently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand and voluntarily sign written informed consent.
- •Male or female subjects, age ≥18, ≤75 years.
- •Confirmed by histopathology or cytopathology, any primary or secondary malignant peritoneal carcinomatosis subject.
- •Progression after standard treatment, or inability to tolerate standard treatment, or no standard treatment.
- •ECOG status 0 to 2 or KPS status > 60
- •CT-PCI (Peritoneal Carcinomatosis Index) status ≥ 15
- •Life expectancy of at least 3 months.
- •No serious hematologic, hepatic, renal dysfunction, comply with the following laboratory test results:
- •Hematology: white blood cell count >3*109/L, absolute neutrophil count ≥1.5*109/L, platelets > 75*109/L, hemoglobin > 90 g/L.
- •Liver function: aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN, Alkaline phosphatase (ALP) ≤ 2.5 times ULN; serum total bilirubin (TBIL) ≤ 1.5 times ULN.
- •Renal function: Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 50 mL/min.
- •All adverse events from previous system anticancer treatment return to baseline or ≤ grade 1 (except for alopecia and vitiligo, neuropathy which induced by previous anticancer therapy status stable or ≤ grade 2).
- •Male or female subjects undergo effective contraception during treatment and within 6 months after last dose.
排除标准
- •Previous treatment with TRAIL pathway drug.
- •Malignant cancer diseases other than malignant peritoneal carcinomatosis in this study (Exceptions include: a cured malignant cancer without relapse within 3 years prior to the study enrollment, completely resected basal cells and squamous cell skin cancer, and any type of carcinoma in situ).
- •Primary lesion invades the central nervous system (CNS) with symptoms develop, status unstable or require high dose steroids (e.g. dexamethasone ≥ 10 mg or equivalent dose) to control.
- •Abnormal HBV examination, anti-HCV positive, anti-HIV antibody positive or other serious infections requiring systemic treatment within 4 weeks prior to first dosing (e.g. virus, bacteria or fungus).
- •Use the following concomitant therapy before dosing:
- •Use drug that prolongs the QT interval and/or associated with the risk of torsades de pointes ventricular tachycardia (TdP) within 7 days prior to first dosing.
- •Use amiodarone within 90 days prior to first dosing.
- •Impaired heart function or clinically significant cardiovascular disease, including any of the following:
- •Cerebrovascular accident/stroke (within 6 months prior to enrollment).
- •Myocardial infarction (within 6 months prior to enrollment).
- •Unstable angina, congestive heart failure (New York Heart Association grade ≥ II) or severe arrhythmia requiring medication (including QT/QTc interval extension >480 msec, installation of pacemakers, etc.).
- •Left ventricular ejection fraction < 50% as determined by echocardiography.
- •Active bleeding history or gastrointestinal perforation risk within 4 weeks before enrollment, or not healed from recent surgery.
- •Received anticancer treatment within following specified time before first dosing:
- •Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whichever is longer).
- •Underwent major surgery within ≤ 4 weeks before first dosing.
- •Residual adverse events from previous treatment≥ grade
- •Known to have alcohol and/or drug dependence.
- •Previous clear history of neurological or mental disorders, such as epilepsy, poor compliance
- •Female subjects with positive blood pregnancy tests or during lactation.
- •Previously allergic to macromolecular protein drugs or proteins or Quincke's edema (Kunke edema, also known as angioedema) or allergic to any component of the SCB
- •Known history of infection with human immunodeficiency virus, or other acquired, innate immune deficiency diseases, or history of organ transplantation.
- •Vaccination within ≤ 4 weeks prior to first dosing, or planning live vaccination.
- •For other reasons according to investigators, not suitable for participation in the trial.
研究组 & 干预措施
SCB-313
Experimental
干预措施: SCB-313 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 21 days after first dosing
DLT
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 21 days after first dosing
AEs
次要结局
- Pharmacokinetics (Cmax)(Up to 24 hours after dosing)
- Pharmacokinetics (tmax)(Up to 24 hours after dosing)
- Immunogenicity(28 days after last dosing)
- Pharmacokinetics ([AUC]0-24)(Up to 24 hours after dosing)
- Pharmacokinetics (AUC 0-inf)(Up to 24 hours after dosing)
研究者
研究点 (1)
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