imotuzumab cold kit for the immunodiagnosis of solid tumors

Phase 1

Not yet recruiting

• Conditions: Tumors of head and neck, lung and gliomas; Head and Neck Neoplasms; Lung Neoplasms; Glioma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Neuroepithelia; Neoplasms, Glandular and Epithelial

• Registration Number: RPCEC00000290
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-05
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who have signed the informed consent.
2. Patients that meet the diagnostic criteria.
3. Patients with biopsy samples that allow IHC study of overexpression of EGFR, imaging study and clinical documentation to corroborate the existence of the lesions.
4. Patients of both sexes older than 18 years.
5. Patients with life expectancy of 3 months or more.
6. Patients with functional status according to the ECOG scale = 2, (Eastern Cooperative Oncology Group) ECOG.
7. Patients with functioning of organs and bone marrow defined by the following parameters:
Hemoglobin greater than or equal to 90 g / L.
Total leukocyte count greater than or equal to 3.0 x 109 / L
Platelet count greater than or equal to 100 x 109 / L.
Bilirubin: Within normal limits for each institution
Glycemia Within normal limits for each institution
ALP: up to 2.5 times the normal upper limit for each institution.
LDH: Within normal limits for each institution
GOT/GPT: up to 2.5 times the normal upper limit for each institution.
Creatinine: Within normal limits for each institution.

Exclusion Criteria

1. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases.
2. Patients who are receiving another product under investigation.
3. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody.
4. Patients with uncontrolled intercurrent diseases, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that could limit adherence to trial requirements.
5. Female patients who are pregnant, nursing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified