Radioisotopes Research Today is a free monthly online journal that collates and summarizes the latest research about Radioisotopes, including details on radioimmunotherapy, radionuclides, procedures, hazards.

Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: clinical phase I/II trials.

Chen ZN, Mi L, Xu J, Song F, Zhang Q, Zhang Z, Xing JL, Bian HJ, Jiang JL, Wang XH, Shang P, Qian AR, Zhang SH, Li L, Li Y, Feng Q, Yu XL, Feng Y, Yang XM, Tian R, Wu ZB, Leng N, Mo TS, Kuang AR, Tan TZ, Li YC, Liang DR, Lu WS, Miao J, Xu GH, Zhang ZH, Nan KJ, Han J, Liu QG, Zhang HX, Zhu P

Cell Engineering Research Centre and Department of Cell Biology, State Key Laboratory of Cancer Biology, Fourth Military Medical University, Xi'an, China.

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.

Published 12 May 2006 in Int J Radiat Oncol Biol Phys, 65(2): 435-44.
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