AntiCEA M3-I

Phase 1

Recruiting

• Conditions: Colorectal cancer; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Rectal Diseases; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

• Registration Number: RPCEC00000042
• Lead Sponsor: Center for Genetic Engineering and Biothecnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Histological diagnosis of colon or rectum adenocarcinoma, any clinical stage, with no previous Onco-specific treatment. Demonstration of CEA antigen expression in tumoral tissue using immunohistochemical technique. General clinical condition lower than or equal to 2 under WHO criteria. Patients aged 18 to 80, both sexes, any race. Contraceptive use in reproductive age women. Patients giving informed consent in writing to participate in the research and undergo relevant tests.

Exclusion Criteria

History of neoplasia other than basocellular skin carcinoma or in situ cervix carcinoma. Previous onco-specific treatment. Previous administration of any murine, chimeric or humanized antibody. History of allergy or hypersensitivity to iodine-containing preparations. Uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, viral hepatitis, and high blood pressure. Hemoglobin values <10 g/L, total leucocytes <4,000/mm3, and platelets <100 x 109 cel/L. Kidney failure caused by creatinine clearing values < 60 mL/min, and liver failure caused by TGP and/or TGO values 2.5 times higher than the normal upper limit in technique under use. Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.50C). Pregnancy, breastfeeding or puerperium. Reproductive age women with positive pregnancy tests. Serious psychiatric or neurological disorder or mental handicap.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmaceutical safety, measuring time: 6 months.

Secondary Outcome Measures

Name	Time	Method
Biodistribution and internal dosage, measuring time: 72 hours. Pharmacokinetics, measuring time: 72 hours.