RPCEC00000290尚未招募1 期
Efficacy and safety of cold kit of monoclonal antibody nimotuzumab labeled with 99mTc for the immunodiagnosis of head and neck tumors, lung and gliomas - Nimo cold kit
Center of Molecular Immunology (CIM)0 个研究点开始时间: 2018年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Diagnostic
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients who have signed the informed consent.
- •2. Patients that meet the diagnostic criteria.
- •3. Patients with biopsy samples that allow IHC study of overexpression of EGFR, imaging study and clinical documentation to corroborate the existence of the lesions.
- •4. Patients of both sexes older than 18 years.
- •5. Patients with life expectancy of 3 months or more.
- •6. Patients with functional status according to the ECOG scale = 2, (Eastern Cooperative Oncology Group) ECOG.
- •7. Patients with functioning of organs and bone marrow defined by the following parameters:
- •Hemoglobin greater than or equal to 90 g / L.
- •Total leukocyte count greater than or equal to 3.0 x 109 / L
- •Platelet count greater than or equal to 100 x 109 / L.
- •Bilirubin: Within normal limits for each institution
- •Glycemia Within normal limits for each institution
- •ALP: up to 2.5 times the normal upper limit for each institution.
- •LDH: Within normal limits for each institution
- •GOT/GPT: up to 2.5 times the normal upper limit for each institution.
- •Creatinine: Within normal limits for each institution.
排除标准
- •1. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases.
- •2. Patients who are receiving another product under investigation.
- •3. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody.
- •4. Patients with uncontrolled intercurrent diseases, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that could limit adherence to trial requirements.
- •5. Female patients who are pregnant, nursing.
研究者
相似试验
尚未招募
1 期
imotuzumab in COVID-19COVID-19SARS-CoV2Coronavirus InfectionsSARS VirusCoronaviridae InfectionsBetacoronavirusAcute DiseaseCritical CareRPCEC00000369Center of Molecular Immunology (CIM)40
进行中（未招募）
1 期
Safety, Tolerability and Efficacy of the Therapeutic Antibody Felzartamab in Rejection Late After Kidney Transplantatioate active or chronic active antibody-mediated rejectionEUCTR2021-000545-40-DEMedical University of Vienna20
进行中（未招募）
1 期
Safety, Tolerability and Efficacy of the Therapeutic Antibody Felzartamab in Rejection Late After Kidney Transplantatioate active or chronic active antibody-mediated rejectionEUCTR2021-000545-40-ATMedical University of Vienna22
已完成
不适用
The study of the efficacy of new generation cryoablation system (CryoICE) in the surgical treatment of atrial fibrillatioAtrial fibrillationJPRN-UMIN000023746ippon Medical School, Department of Cariovascular Surgery20
进行中（未招募）
1 期
Protection, Immune Response, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile InfectioPrevention of primary Clostridium difficile infectionMedDRA version: 20.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2013-000775-32-PLSanofi Pasteur Inc16,500