Her1 vaccine in metastatic colon and prostate cancer

Phase 1

• Conditions: prostate and colon cancer; Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases; Genital Diseases, Male; Male Urogenital Diseases; Colonic Neoplasms; Colorectal Neoplasms

• Registration Number: RPCEC00000431
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Last Update Posted: 19 August 2024
• Study Completion: 2026-02-03
• Results First Posted: 2026-05-03

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with serious adverse events with a causal relationship (according to CTCAE criteria and causality criteria: SAE with very probable, probable or possible causation). Measurement time: at all times of administration of the research product.