Phase I-II study of dose escalation and cohort expansion with synthetic VSSP in patients with metastatic renal carcinoma

Center of Molecular Immunology (CIM)0 个研究点目标入组 70 人开始时间: 2023年6月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment

•1. Patients who meet the diagnostic criteria of CRM or relapse, operated or not, who have received the standard 1st line treatment (recombinant IFN a2), and have completed it at least 3 months before inclusion
•2. Patients who have not received the standard 1st line treatment (recombinant IFN a2), due to non-tolerance or contraindication.
•3. Patients who give their informed consent for participation in writing.
•4. Patients of any sex over 18 years of age.
•5. Patients with general condition = 2 (according to ECOG).
•6. Patients with a life expectancy of at least 6 months.
•7. Patients who meet the following laboratory parameters:
•Hb = 8.5 g / dL
•Total leukocyte count = 3 x 109 / L
•Platelet count = 100 x 109 / L
•Total bilirubin = 2 times the normal value for each institution.
•LDH = 2 times the normal value for each institution.
•Creatinine = 2 times the normal value for each institution.

•1. Patients of childbearing age who are not using an adequate method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation).
•2. Pregnant or lactating patients.
•3. Patients with acute allergic states or history of severe allergic reactions.
•4. Patients with decompensated acute or chronic lung diseases that may interfere with the follow-up of the underlying disease.
•5. Patients with a previous history of demyelinating or inflammatory diseases of the Central Nervous System (CNS) or Peripheral (SNP).
•6. Patients with uncontrolled intercurrent diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric diseases that imply the incompetence of the subject.
•7. Patients receiving another investigational product.
•8. Patients with known hypersensitivity to any component of the formulation.
•9. Patients with known positive serology for HIV, hepatitis B or C.

发起方

Center of Molecular Immunology (CIM)