Phase I/II trial with the mutein no alfa of IL-2

Phase 1

• Conditions: Solid tumors; Neoplasms

• Registration Number: RPCEC00000234
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients who give their written informed consent to participate.
3. Patients of either sex aged over 18 years.
4. Patients generally = 2 state (as ECOG).
5. Patients with a life expectancy of at least 6 months.
6. Patients having functioning of organs and bone marrow under pre-defined parameters.

Exclusion Criteria

1. Patients of childbearing age who are not using an appropriate method of contraception prior to inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condom use).
2. Pregnant or lactating patients.
3. Patients with acute allergic conditions or history of severe allergic reactions.
4. Patients with acute decompensated chronic lung disease or that may interfere with the monitoring of the underlying disease.
5. Patients with previous history of demyelinating inflammatory or central nervous system disease (CNS) or peripheral (PNS).
6. Patients suffering from uncontrolled intercurrent illness including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, diabetes mellitus and psychiatric diseases involving the incompetence of the subject.
7. Patients with brain metastases.
8. Patients who are receiving other investigational product.
9. Patients with known hypersensitivity to any component of the formulation.
10. Patients with known HIV positive serology, hepatitis B or C.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose-MTD (Level where included 6 subjects). Measuring time: at the end of stage I. The MTD will use in the stage II (expansion to 3 cohort of patients according to tumor type)<br>Serious adverse events with causality relationship proved (definitive, very likely, likely) with product administration. Measuring time: every 1 or 4 hours if needed during product administration.<br>