Phase I Studies of Peptide Vaccine Cocktails Derived from GPC3, WDRPUH and NEIL3 for Advanced Hepatocellular Carcinoma
Masafumi Ikeda, Takuji Okusaka, Izumi Ohno, Shuichi Mitsunaga, Shunsuke Kondo, Hideki Ueno, Chigusa Morizane, Kazuto Gemmoto, Hideaki Suna, Yasunori Ushida, Junji Furuse
Abstract
Aim: Two peptide cocktail vaccines using glypican-3, WD-repeat-containing protein up-regulated in hepatocellular carcinoma (HCC) and nei endonuclease VIII-like three epitopes were evaluated in advanced HCC in two Phase I studies. Patients & methods: Study 1 evaluated dose-limiting toxicities (DLTs) of peptides 1–3 (HLA-A24-restricted) and study 2 evaluated DLTs of peptides 1–6 (HLA-A24 or A02-restricted). Results: Overall, 18 and 14 patients were enrolled in studies 1 and 2, respectively. No DLTs were observed up to 7.1 mg of the vaccine cocktail. No complete response/partial response was observed. Stable disease was reported in nine and five patients with a disease control rate of 52.9% and 35.7% in studies 1 and 2, respectively. Conclusion: Both vaccines showed good tolerability and potential usefulness against HCC. Clinical trial registration: JapicCTI-121933; JapicCTI-142477