imotuzumab cold kit for the immunodiagnosis of solid tumors

Phase 1

• 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: 19 August 2024

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

Primary Outcome Measures

Name	Time	Method
1. Degree of graphic gamma positivity (InGG immunography will be performed to determine the degree of concordance, sensitivity, specificity, positive predictive value, negative predictive value). Measurement time: at 4 and 18-24 hours after the administration of Radioimmunoconjugate. <br>2. Overexpression of the EGFR (overexpression of EGFR in the biopsy as High, Moderate, Low, Negative). Measurement time: At baseline.

Secondary Outcome Measures

Name	Time	Method
Adverse events (Incidence of Adverse Events (AE) reported by the patient and by laboratory tests measured as: Occurrence of any AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between the start and end date of the AE); Intensity of the AE (Light, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious, Not serious); Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or squeal], Causal relationship (1. Definitive 2. Very probable, 3. Probable, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: 28 days after administration