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Phase I clinical trial of the (131)I-labeled anticarcinoembryonic antigen CIGB-M3 multivalent antibody fragment.

Authors
  • González, Gilmara Pimentel
  • García, Idrian García
  • González, Joaquín González
  • Sánchez, Lincidio Pérez
  • Mirabal, Milagros Velasco
  • Marín, Carlos Calderón
  • Ruiz, Fausto L García
  • Iglesias, Elizeth Garcia
  • de Queralta, Rosalina López
  • Toirac, Ramón Ropero
  • Avila, Marta Ayala
  • Díaz, Adlín López
  • Saura, Pedro A López
  • Gavilondo, Jorge V
  • González, Juan P Oliva
Type
Published Article
Journal
Cancer Biotherapy & Radiopharmaceuticals
Publisher
Mary Ann Liebert
Publication Date
Jun 01, 2011
Volume
26
Issue
3
Pages
353–363
Identifiers
DOI: 10.1089/cbr.2010.0899
PMID: 21711100
Source
Medline
License
Unknown

Abstract

Center for Genetic Engineering and Biotechnology (CIGB)-M3 is a trivalent recombinant single-chain Fv antibody fragment specific for carcinoembryonic antigen (CEA). Preclinical studies with radiolabeled CIGB-M3 have showed that the antibody fragment accumulates in human colon tumor xenografts growing in nude mice. A Phase I clinical trial was carried out to determine safety, biodistribution, and pharmacokinetics of the radiolabeled CIGB-M3 in two groups of patients with CEA+ colorectal cancers. Group I (10 patients) received a single intravenous injection of 0.3 mg of (131)I-CIGB-M3 (16.7-23.3 mCi/mg). Group II (7 patients) received 1 mg (5-7 mCi/mg). No adverse events related to the injected product were recorded, and no immunology response was detected up to 6 months after the injection. Tumors were detected in 15 of the 17 studied cases. The pharmacokinetic profile showed beta half-times of 14.1 and 6.3 hours for Groups I and II, respectively. Seventy-two (72) hours after the administration of the product, 85% of the total injected activity was excreted in urine in the form of free (131)I. The kidneys were identified as the organs that can limit the maximum tolerated dose. The (131)I-CIGB-M3 was safe in patients with colorectal cancer. The biodistribution and pharmacokinetic data suggest that the product can be further tested for molecular radiotherapy of CEA+tumors.

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