Phase I/II study with the HER1 therapeutic vaccine in patients with asymptomatic or minimally symptomatic hormonal castration-resistant prostate cancer or metastatic colon cancer.

Center of Molecular Immunology (CIM)0 个研究点目标入组 88 人开始时间: 2023年8月16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: Single Group. Purpose: Treatment

•1. Compliance with one of the two diagnostic criteria defined for each disease (CPRC, CCM).
•2. Patient who gives their informed consent to participate in writing. 3. Age over 18 years.
•3. General condition according to ECOG = 2.
•4. Life expectancy of at least 6 months.
•5. Organ and bone marrow function defined by the following parameters:
•- Hemoglobin (Hb) = 9 g/dl,
•- Total leukocyte count = 3 x 109/L,
•- Platelet count (PC) = 100 x 109/L ,
•- Total bilirubin and/or Alkaline Phosphatase = 2.5 times the institutional upper normal limit.

•1. Patients of childbearing age who are not using an adequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or surgical sterilization) prior to their inclusion in the study.
•2. Pregnant or lactating.
•3. Known positive serology for HIV, hepatitis B or C.
•4. Decompensated allergic states or history of severe allergic reactions.
•5. Acute or chronic decompensated lung diseases.
•6. Previous history of demyelinating or inflammatory diseases of the central (CNS) or peripheral (PNS) nervous system.
•7. Uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, Diabetes Mellitus and/or psychiatric illness involving the incompetence of the subject.
•8. Brain metastasis.
•9. Known hypersensitivity to any component of the formulation.
•10. Patients who are receiving another investigational product.

发起方

Center of Molecular Immunology (CIM)