A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) in Patients With Unresectable/Metastatic Melanoma

Biocad8 个研究点分布在 1 个国家目标入组 15 人开始时间: 2017年10月2日最近更新: 2019年5月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Biocad
入组人数: 15
试验地点: 8
主要终点: Number of participants with Dose-Limiting Toxicities (DLTs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
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

•Patient provides a written informed consent and is able to follow the requirements of the Protocol;
•Age ≥ 18 years
•Histologically confirmed (well-documented test results; preferably, block specimens available) unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
•ECOG score of 0 to 2;
•Measurable disease (at least one lesion) according to RECIST v1.1 ;
•Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to ≤ grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia);
•No severe pathology of organs or systems;
•Life expectancy of at least 16 weeks from the screening;
•Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-145.

排除标准

•Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);
•Brain metastases ;
•Severe cardiovascular disorders within 6 months before screening;
•Autoimmune diseases;
•Conditions requiring steroids or any other immunosuppressants;
•Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
•Renal function impairment: creatinine ≥1.5 × ULN;
•Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
•Endocrine disorders: abnormal thyroid hormones
•Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
•Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
•Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
•Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
•Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
•Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
•Acute infections or active chronic infections;
•Documented hepatitis B, active hepatitis C, HIV or syphilis infection;
•Intravenous administration of the drug is impossible;
•Intravenous administration of contrast agents is impossible;
•Hypersensitivity to any component of BCD-
•Known history of hypersensitivity to monoclonal antibodies;
•Pregnancy or breastfeeding;