PURPOSE:HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine (131I) metuximab injection (Licartin), a novel 131I-labeled HAb18G/CD147-specific monoclonal antibody Fab'2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. METHODS AND MATERIALS: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. RESULTS:No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p < 0.0001 or p = 0.0019). CONCLUSION:Iodine (131I) metuximab injection is safe and active for HCC patients.
RCT Entities:
PURPOSE: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine (131I) metuximab injection (Licartin), a novel 131I-labeled HAb18G/CD147-specific monoclonal antibody Fab'2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. METHODS AND MATERIALS: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. RESULTS: No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p < 0.0001 or p = 0.0019). CONCLUSION:Iodine (131I) metuximab injection is safe and active for HCC patients.
Authors: J Tang; Y-S Guo; Y Zhang; X-L Yu; L Li; W Huang; Y Li; B Chen; J-L Jiang; Z-N Chen Journal: Cell Death Differ Date: 2012-05-18 Impact factor: 15.828
Authors: Jorge A Carrasquillo; Neeta Pandit-Taskar; Joseph A O'Donoghue; John L Humm; Pat Zanzonico; Peter M Smith-Jones; Chaitanya R Divgi; Daniel A Pryma; Shutian Ruan; Nancy E Kemeny; Yuman Fong; Douglas Wong; Jaspreet S Jaggi; David A Scheinberg; Mithat Gonen; Katherine S Panageas; Gerd Ritter; Achim A Jungbluth; Lloyd J Old; Steven M Larson Journal: J Nucl Med Date: 2011-07-15 Impact factor: 10.057
Authors: Scott T Tagawa; Matthew I Milowsky; Michael Morris; Shankar Vallabhajosula; Paul Christos; Naveed H Akhtar; Joseph Osborne; Stanley J Goldsmith; Steve Larson; Neeta Pandit Taskar; Howard I Scher; Neil H Bander; David M Nanus Journal: Clin Cancer Res Date: 2013-05-28 Impact factor: 12.531