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Abstract
BackgroundI-124 codrituzumab (aka GC33), an antibody directed at Glypican 3, was evaluated in patients with hepatocellular carcinoma (HCC). Fourteen patients with HCC underwent baseline imaging with I-124 codrituzumab (~ 185 MBq, 10 mg). Seven of these patients undergoing sorafenib/immunotherapy with 2.5 or 5 mg/kg of cold codrituzumab had repeat imaging, with co-infusion of I-124 codrituzumab, as part of their immunotherapy treatment. Three patients who progressed while on sorafenib/immunotherapy were re-imaged after a 4-week washout period to assess for the presence of antigen. Serial positron emission tomography (PET) imaging and pharmacokinetics were performed following I-124 codrituzumab. An ELISA assay was used to determine “cold” codrituzumab serum pharmacokinetics and compare it to that of I-124 codrituzumab. Correlation of imaging results was performed with IHC. Short-term safety assessment was also evaluated.ResultsThirteen patients had tumor localization on baseline I-124 codrituzumab; heterogeneity in tumor uptake was noted. In three patients undergoing repeat imaging while on immunotherapy/sorafenib, evidence of decreased I-124 codrituzumab uptake was noted. All three patients who underwent imaging after progression while on immunotherapy continued to have I-124 codrituzumab tumor uptake. Pharmacokinetics of I-124 codrituzumab was similar to that of other intact IgG. No significant adverse events were observed related to the I-124 codrituzumab.ConclusionsI-124 codrituzumab detected tumor localization in most patients with HCC. Pharmacokinetics was similar to that of other intact iodinated humanized IgG. No visible cross-reactivity with normal organs was observed.
Highlights
I-124 codrituzumab, an antibody directed at Glypican 3, was evaluated in patients with hepatocellular carcinoma (HCC)
In seven patients undergoing injection with cold codrituzumab, additional analysis in this study confirmed that the clearance kinetics of the I-124 codrituzumab was similar to that of the parent based on an ELISA assay [27]
No significant differences were observed when we compared the pharmacokinetics and area underneath the curve (AUC) of the cold antibody based on ELISA and the I-124-labeled antibody based on radioactivity measurements; this suggests that the radioiodination did not significantly damage the antibody
Summary
I-124 codrituzumab (aka GC33), an antibody directed at Glypican 3, was evaluated in patients with hepatocellular carcinoma (HCC). Fourteen patients with HCC underwent baseline imaging with I-124 codrituzumab (~ 185 MBq, 10 mg). Seven of these patients undergoing sorafenib/immunotherapy with 2.5 or 5 mg/kg of cold codrituzumab had repeat imaging, with co-infusion of I-124 codrituzumab, as part of their immunotherapy treatment. Serial positron emission tomography (PET) imaging and pharmacokinetics were performed following I-124 codrituzumab. Initial radiolabeled antibody studies focused on the use of radionuclides that were single-photon emitters such as I-131- and In-111-labeled reagents. These singlephoton-emitting isotopes had limitations in terms of lack of quantitation and in terms of sensitivity and resolution of the scanners. These limitations are largely overcome by the use of positron-emitting radiopharmaceuticals that
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