Exploratory, open and multicenter study of the use of the humanized monoclonal antibody itolizumab (antiCD6) in patients with solid tumors.

Phase 1

• Conditions: Solid tumors CD 318+, Breast cancer, Colon cancer, Ovarian cancer

• Registration Number: RPCEC00000444
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-18
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31
• Results First Posted: 2025-12-15

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients who give their informed consent for participation in writing.
3. Patients of either sex aged over 18 years.
4. Patients with general condition = 2 (according to ECOG)
5. Patients with life expectancy of at least 3 months.
6. Patients who do not agree to receive another available cancer treatment option.
7. Patients with organ and bone marrow function defined by the following parameters: Hemoglobin = 10 g/dl,total Leukocyte Count = 3 x 109/L,Platelet count = 100 x 109/L, total bilirubin: within normal limits for the institution, TGP and TGO =2.5 times the institutional upper normal limit, creatinine:within normal limits for the institution.

Exclusion Criteria

1. Patients of childbearing age who are not using an adequate method of contraception prior to inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of the male sex (vasectomy, use of condoms).
2. Pregnant or lactating patients.
3. Patients with acute allergic states or a history of severe allergic reactions.
4. Patients with acute or chronic decompensated lung diseases that may interfere with the monitoring of the underlying disease.
5. Patients with intercurrent uncontrolled 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 incompetence of the subject.
6. Patients who are receiving another investigational product or have recently finished the use of any monoclonal antibody.
7. Patients with known hypersensitivity to any component of the formulation.
8. Patients with known positive serology for HIV, hepatitis B or C.

Study & Design

• Study Type: Interventional
• Study Design: Not specified