First-in-man phase i study of GC33, a novel recombinant humanized antibody against glypican-3, in patients with advanced hepatocellular carcinoma

Clinical Cancer Research

Volumn 19, Issue 4, 2013, Pages 920-928

  Zhu, Andrew X ^a   Gold, Philip J ^c   El Khoueiry, Anthony B ^d   Abrams, Thomas A ^b   Morikawa, Hideo ^e   Ohishi, Norihisa ^e   Ohtomo, Toshihiko ^e   Philip, Philip A ^f  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c SWEDISH MEDICAL CENTER   (United States)

^d UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^e CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^f WAYNE STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GC 33; GLYPICAN 3; RECOMBINANT ANTIBODY; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASCITES; CHILL; CLINICAL ARTICLE; CONFUSION; CONSTIPATION; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPNEA; EDEMA; FATIGUE; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPONATREMIA; INFUSION RELATED REACTION; INSOMNIA; JAUNDICE; LIVER CELL CARCINOMA; MALE; MULTICENTER STUDY; NAUSEA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; PRURITUS; SIDE EFFECT; TREATMENT RESPONSE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; CARCINOMA, HEPATOCELLULAR; FEMALE; GLYPICANS; HUMANS; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84874040548     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-2616     Document Type: Article

References (26)

1. Alves RC, Alves D, Guz B, Matos C, Viana M, Harriz M, et al. Advanced hepatocellular carcinoma. Review of targeted molecular drugs. Ann Hepatol 2011;10:21-7.
2. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. Sorafenib in advanced hepatocellular carcinoma. New Eng J Med 2008;359:378-90.
3. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorefanib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomized, double-blind, placebo- controlled trial. Lancet Oncol 2009;10:25-34.
4. Filmus J, Selleck SB. Glypicans: proteoglycans with a surprise. J Clin Invest 2001;108:497-501.
5. Huber R, Hansen RS, Strazzullo M, Pengue G, Mazzarella R, D'Urso M, et al. DNA methylation in transcriptional repression of two differentially expressed X-linked genes, GPC3and SYBL1. Proc Natl Acad SciUSA 1999;96:616-21.
6. Zhu ZW, Friess H, Wang L, Abou-Shady M, Zimmermann A, Lander AD, et al. Enhanced glypican-3 expression differentiates the majority of hepatocellular carcinomas from benign hepatic disorders. Gut 2001; 48:558-64.
7. Capurro M, Wanless IR, Sherman M, Deboer G, Shi W, Miyoshi E, et al. Glypican-3: a novel serum and histochemical marker for hepatocellular carcinoma. Gastroenterology 2003;125:89-97.
8. Yamauchi N, Watanabe A, Hishinuma M, Ohashi K, Midorikawa Y, Morishita Y, et al. The glypican 3 oncofetal protein is a promising diagnostic marker for hepatocellular carcinoma. Mod Pathol 2005;18: 1591-8.
9. Libbrecht L, Severi T, Cassiman D, Vander Borght S, Pirenne J, Nevens F, et al. Glypican-3 expression distinguishes small hepatocellular carcinomas from cirrhosis, dysplastic nodules, and focal nodular hyperplasia-like nodules. Am J Surg Pathol 2006;30:1405-11.
10. Llovet JM, Chen Y, Wurmbach E, Roayaie S, Fiel MI, Schwartz M, et al. A molecular signature to discriminate dysplastic nodules from early hepatocellular carcinoma in HCV cirrhosis. Gastroenterology 2006; 131:1758-67.
11. Wang XY, Degos F, Dubois S, Tessiore S, Allegretta M, Guttmann RD, et al. Glypican-3 expression in hepatocellular tumors: diagnostic value for preneoplastic lesions and hepatocellular carcinomas. Hum Pathol 2006;37:1435-41.
12. Capurro MI, Xiang YY, Lobe C, Filmus J. Glypican-3 promotes the growth of hepatocellular carcinoma by stimulating canonical Wnt signaling. Cancer Res 2005;65:6245-54.
13. Cheng W, Tseng CJ, Lin TT, Cheng I, Pan HW, Hsu HC, et al. Glypican- 3-mediated oncogenesis involves the insulin-like growth factorsignaling pathway. Carcinogenesis 2008;29:1319-26.
14. Lai JP, Sandhu DS, Yu C, Han T, Moser CD, Jackson KK, et al. Sulfatase 2 up-regulates glypican-3, promotes fibroblast growth factor signaling, and decreases survival in hepatocellular carcinoma. Hepatology 2008;47:1211-22.
15. Yorita K, Takahashi N, Takai H, Kato A, Suzuki M, Ishiguro T, et al. Prognostic significance of circumferential cell surface immunoreactivity of glypican-3 in hepatocellular carcinoma. Liver Int 2011;31: 120-31.
16. Ho M, Kim H. Glypican-3: a new target for cancer immunotherapy. Eur J Cancer 2011;47:333-8.
17. Nakano K, Ishiguro T, Konishi H, Tanaka M, Sugimoto M, Sugo I, et al. Generation of a humanized anti-glypican 3 antibody by CDR grafting and stability optimization. Anticancer Drugs 2010;21:907-16.
18. Ishiguro T, Sugimoto M, Kinoshita Y, Miyazaki Y, Nakano K, Tsunoda H, et al. Anti-glypican 3 antibody as a potential antitumor agent for human liver cancer. Cancer Res 2008;68:9832-8.
19. Takai H, Kato A, Kato C, Watanabe T, Matsubara K, Suzuki M, et al. The expression profile of glypican-3 and its relation to macrophage population in human hepatocellular carcinoma. Liver Int 2009;29: 1056-64.
20. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidance to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92: 205-16.
21. Takai H, Kato A, Ishiguro T, Kinoshita Y, Karasawa Y, Otani Y, et al. Optimization of tissue processing for immunohistochemistry for the detection of human glypican-3. Acta Histochem 2010;112:240-50.
22. Hippo Y, Watanabe K, Watanabe A, Midorikawa Y, Yamamoto S, Ihara S, et al. Identification of soluble NH2-terminal fragment of glypican-3 as a serological marker for early-stage hepatocellular carcinoma. Cancer Res 2004;64:2418-23.
23. Kwack MH, Choi BY, Sung YK. Cellular changes resulting from forced expression of glypican-3 in hepatocellular carcinoma cells. Mol Cells 2006;21:224-8.
24. Komiya Y, Habas R: Wnt signal transduction pathways. Organogenesis 2008;4:68-75.
25. Lai JP, Thompson JR, Sandhu DS, Roberts LR. Heparin-degrading sulfatases in hepatocellular carcinoma: roles in pathogenesis and therapy targets. Future Oncol 2008;4:803-14.
26. Akutsu N, Yamamoto H, Sasaki S, Taniguchi H, Arimura Y, Imai K, et al. Association of glypican-3 expression with growth signaling molecules in hepatocellular carcinoma. World J Gastroenterol 2010;16:3521-8.