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Phase I Clinical Trial of the 131 I-Labeled Anticarcinoembryonic Antigen CIGB-M3 Multivalent Antibody Fragment

2011; Mary Ann Liebert, Inc.; Volume: 26; Issue: 3 Linguagem: Inglês

10.1089/cbr.2010.0899

1557-8852

Gilmara Pimentel González, Idrián García García, Joaquín González González, Lincidio Pérez Sánchez, Milagros Velasco Mirabal, Carlos Calderón Marín, Fausto L. García Ruiz, Elizeth García Iglesias, Rosalina López de Queralta, Ramón Ropero Toirac, Matías A. Ávila, Adlin López Díaz, Pedro Antonio López Saura, Jorge Gavilondo, Juan Perfecto Oliva González,

HER2/EGFR in Cancer Research

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 131I-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 131I. The kidneys were identified as the organs that can limit the maximum tolerated dose. The 131I-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.