NCT03050047Unknown1 期
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- Biocad
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- ORR (CR + PR)
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-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors
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 cancer (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);
- •Locally advanced or metastatic NSCLC (squamous cell carcinoma/adenocarcinoma), progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
- •Metastatic clear cell renal carcinoma, progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
- •In addition, by investigator's decision, patients with the following malignancies can also be enrolled in the study :
- •Pleural mesothelioma progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
- •Metastatic bladder cancer progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
- •Triple negative breast cancer (ER-, PR-, HER2-) progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
- •ECOG score of 0 to 2;
- •Measurable disease (at least one lesion) according to RECIST v. 1.1 ;
- •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 12 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-100.
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, progressive or associated with clinical symptoms (e.g. cerebral edema or spinal cord compression). Exclusions: metastases that do not progress and do not require steroids and/or anticonvulsants within at least 4 weeks before randomization ;
- •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;
- •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 HIV infection;
- •Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies ;
- •Positive results of microprecipitation reaction together with positive TPHA assay results at the screening;
- •Body weight > 95 kg.
- •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;
研究组 & 干预措施
BCD-100 10 mg/kg
Experimental
Patients who receive BCD-100 in a dose of 10 mg/kg
干预措施: BCD-100 (Biological)
BCD-100 3 mg/kg
Experimental
Patients who receive BCD-100 in a dose of 3 mg/kg
干预措施: BCD-100 (Biological)
BCD-100 1 mg/kg
Experimental
Patients who receive BCD-100 in a dose of 1 mg/kg
干预措施: BCD-100 (Biological)
BCD-100 0.3 mg/kg
Experimental
Patients who receive BCD-100 in a dose of 0.3 mg/kg
干预措施: BCD-100 (Biological)
结局指标
主要结局
ORR (CR + PR)
时间窗: 85 days
Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug. • ORR (CR + PR) after 85 days of therapy with BCD-100.
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic MelanomaMelanomaNCT03472027Biocad15
Unknown
1 期
A Study of BCD-135 in Patients With Advanced Solid TumorsMelanomaBladder CancerRenal Cell CarcinomaNSCLCNCT03464032Biocad30
已完成
1 期
LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With CrizotinibNon-Small Cell Lung CancerNCT02040870Novartis Pharmaceuticals103
已完成
1 期
The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy SubjectsHealthyNCT03734302Otsuka Beijing Research Institute10
已完成
1 期
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy SubjectsRenal ImpairmentDisease SeverityNCT02199379Eisai Inc.26