AntiCEA M3-I

Evaluation of a multivalent fragment of radiomarked anti-CEA antibody in colorectal cancer patients. Clinical trial, phase I.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000042

Enrollment

Registered

2010-12-20

Start date

2007-05-14

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

The trial will involve 20 adult patients with colorectal cancer, to be divided into 2 10-member groups for each dose level. One single intravenous dose of 0.3 or 1mg of fragment marked with 5-7 mCi of

Antibodies, Monoclonal

Radioimmunodetection

Iodine Radioisotopes

Injections, Intramuscular

131I-antiCEA M3

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmaceutical safety, measuring time: 6 months.	—

Secondary

Measure	Time frame
Biodistribution and internal dosage, measuring time: 72 hours. Pharmacokinetics, measuring time: 72 hours.	—

Countries

Cuba

Contacts

Public ContactIdrian Garcia Garcia

Clinical Trials Division, Center for Biological Research

idrian.garcia@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026