Safety, pharmacokinetics, and pharmacodynamics of AMG 102, a fully human hepatocyte growth factor-neutralizing monoclonal antibody, in a first-in-human study of patients with advanced solid tumors

Clinical Cancer Research

Volumn 16, Issue 2, 2010, Pages 699-710

  Gordon, Michael S ^a   Sweeney, Christopher S ^b   Mendelson, David S ^a   Eckhardt, S Gail ^c   Anderson, Abraham ^d   Beaupre, Darrin M ^d   Branstetter, Daniel ^d   Burgess, Teresa L ^d   Coxon, Angela ^d   Deng, Hongjie ^d   Kaplan Lefko, Paula ^d   Leitch, Ian M ^d   Oliner, Kelly S ^d   Yan, Lucy ^d   Zhu, Min ^d   Gore, Lia ^c  

^a Premiere Oncology of Arizona   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^d AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMG 102; CA 125 ANTIGEN; DRUG ANTIBODY; MONOCLONAL ANTIBODY; SCATTER FACTOR; SCATTER FACTOR RECEPTOR;

ADULT; ADVANCED CANCER; AGED; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANOREXIA; ANTIBODY PRODUCTION; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BLADDER CANCER; BREAST CANCER; CANCER SURVIVAL; CARCINOID; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CANCER; COLON FISTULA; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; GALLBLADDER CARCINOMA; GLIOBLASTOMA; HUMAN; HYPERTENSION; HYPOXIA; KIDNEY CANCER; LIVER CELL CARCINOMA; LUNG CANCER; LUNG NON SMALL CELL CANCER; LYMPH NODE METASTASIS; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MOUSE; MYALGIA; NAUSEA; NEUROENDOCRINE TUMOR; NONHUMAN; OVARY CANCER; PANCREAS CANCER; PERIPHERAL EDEMA; PERITONEUM CANCER; PERIVASCULAR EPITHELIOID TUMOR; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; RETROPERITONEAL SARCOMA; SALIVARY GLAND CARCINOMA; SMALL INTESTINE CANCER; SOFT TISSUE SARCOMA; SOLID TUMOR; STOMACH CANCER; SURVIVAL RATE; SURVIVAL TIME; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER GASTROINTESTINAL BLEEDING; UTERUS CANCER;

ADULT; AGED; ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE, NEOPLASM; FEMALE; HEPATOCYTE GROWTH FACTOR; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MICE; MIDDLE AGED; NEOPLASMS; TUMOR CELLS, CULTURED; XENOGRAFT MODEL ANTITUMOR ASSAYS; YOUNG ADULT;

EID: 74549174584     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-09-1365     Document Type: Article

References (43)

1. Stoker M, Gherardi E, Perryman M, Gray J. Scatter factor is a fibroblast-derived modulator of epithelial cell mobility. Nature 1987;327:239-42.
2. Zarnegar R, Michalopoulos G. Purification and biological characterization of human hepatopoietin A, a polypeptide growth factor for hepatocytes. Cancer Res 1989;49:3314-20.
3. Montesano R, Matsumoto K, Nakamura T, Orci L. Identification of a fibroblast-derived epithelial morphogen as hepatocyte growth factor. Cell 1991;67:901-8.
4. Nakamura T, Nishizawa T, Hagiya M, et al. Molecular cloning and expression of human hepatocyte growth factor. Nature 1989;342:440-3.
5. Birchmeier C, Birchmeier W, Gherardi E, Vande Woude GF. Met, metastasis, motility and more. Nat Rev Mol Cell Biol 2003;4:915-25.
6. Ferracini R, Di Renzo MF, Scotlandi K, et al. The Met/HGF receptor is over-expressed in human osteosarcomas and is activated by either a paracrine or an autocrine circuit. Oncogene 1995;10:739-49.
7. Jin L, Fuchs A, Schnitt SJ, et al. Expression of scatter factor and c-met receptor in benign and malignant breast tissue. Cancer 1997;79:749-60.
8. Fukuura T, Miki C, Inoue T, Matsumoto K, Suzuki H. Serum hepatocyte growth factor as an index of disease status of patients with colorectal carcinoma. Br J Cancer 1998;78:454-9.
9. Koochekpour S, Jeffers M, Rulong S, et al. Met and hepatocyte growth factor/scatter factor expression in human gliomas. Cancer Res 1997;57:5391-8.
10. Schmidt L, Junker K, Nakaigawa N, et al. Novel mutations of the MET proto-oncogene in papillary renal carcinomas. Oncogene 1999;18:2343-50.
11. Miller M, Ginalski K, Lesyng B, Nakaigawa N, Schmidt L, Zbar B. Structural basis of oncogenic activation caused by point mutations in the kinase domain of the MET proto-oncogene: modeling studies. Proteins 2001;44:32-43.
12. Di Renzo MF, Olivero M, Martone T, et al. Somatic mutations of the MET oncogene are selected during metastatic spread of human HNSC carcinomas. Oncogene 2000;19:1547-55.
13. Olivero M, Valente G, Bardelli A, et al. Novel mutation in the ATP-binding site of the MET oncogene tyrosine kinase in a HPRCC family. Int J Cancer 1999;82:640-3.
14. Di Renzo MF, Olivero M, Giacomini A, et al. Overexpression and amplification of the met/HGF receptor gene during the progression of colorectal cancer. Clin Cancer Res 1995;1:147-54.
15. Nakajima M, Sawada H, Yamada Y, et al. The prognostic significance of amplification and overexpression of c-met and c-erb B-2 in human gastric carcinomas. Cancer 1999;85:1894-902.
16. Kijima Y, Hokita S, Yoshinaka H, et al. Amplification and overexpression of c-met gene in Epstein-Barr virus-associated gastric carcinomas. Oncology 2002;62:60-5.
17. Comoglio PM, Giordano S, Trusolino L. Drug development of MET inhibitors: targeting oncogene addiction and expedience. Nat Rev Drug Discov 2008;7:504-16.
18. Burgess T, Coxon A, Meyer S, et al. Fully human monoclonal antibodies to hepatocyte growth factor with therapeutic potential against hepatocyte growth factor/c-Met-dependent human tumors. Cancer Res 2006;66:1721-9.
19. Martin TA, Parr C, Davies G, et al. Growth and angiogenesis of human breast cancer in a nude mouse tumour model is reduced by NK4, a HGF/SF antagonist. Carcinogenesis 2003;24:1317-23.
20. Sattler M, Salgia R. c-Met and hepatocyte growth factor: potential as novel targets in cancer therapy. Curr Oncol Rep 2007;9:102-8.
21. Kakkar T, Ma M, Zhuang Y, Patton A, Hu Z, Mounho B. Pharmacokinetics and safety of a fully human hepatocyte growth factor antibody, AMG 102, in cynomolgus monkeys. Pharm Res 2007;24:1910-8.
22. Data on file. Thousand Oaks (CA): Amgen Inc. 2008.
23. Athauda G, Giubellino A, Coleman JA, et al. c-Met ectodomain shedding rate correlates with malignant potential. Clin Cancer Res 2006;12:4154-62.
24. Therasse P, Arbuck SG, Eisenhauer EA, et al. European Organization for Research and Treatment of CancerNational Cancer Institute of the United StatesNational Cancer Institute of Canada. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
25. 18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. Eur J Cancer 1999;35:1773-82.
26. Hogdall E. Cancer antigen 125 and prognosis. Curr Opin Obstet Gynecol 2008;20:4-8.
27. Jhawer MP, Kindler HL, Wainberg ZA, et al. Preliminary activity of XL880, a dual MET/VEGFR2 inhibitor, in MET amplified poorly differentiated gastric cancer (PDGC): interim results of a multicenter phase II study [abstract]. J Clin Oncol 2008;26:4572.
28. Ross RW, Srinivasan R, Vaishampayan U, et al. A phase 2 study of the dual MET/VEGFR2 inhibitor XL880 in patients (pts) with papillary renal carcinoma (PRC) [abstract]. In: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, November 14-18, 2007, San Francisco (CA). 2007.
29. Shapiro GI, Heath E, Malburg L, et al. A phase I dose-escalation study of the safety, pharmacokinetics (PK) and pharmacodynamics of XL880, a VEGFR and MET kinase inhibitor, administered daily to patients (pts) with advanced malignancies [abstract]. In: AACRNCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, November 14-18, 2007, San Francisco (CA) 2007.
30. Yap TA, Harris D, Barriuso J, et al. Phase I trial to determine the dose range for the c-Met inhibitor ARQ 197 that inhibits c-Met and FAK phosphorylation, when administered by an oral twice-a-day schedule [abstract]. J Clin Oncol 2008;26:3584.
31. Rosen L, Senzer N, Nemunaitis J, et al. A phase I dose escalation study and signs of anti-metastatic activity of ARQ 197, A selective c-Met inhibitor [abstract]. In: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, November 14-18, 2007, San Francisco (CA). 2007.
32. Salgia R, Sherman S, Hong DS, et al. A phase I study of XL184, a RET, VEGFR2, and MET kinase inhibitor, in patients (pts) with advanced malignancies, including pts with medullary thyroid cancer (MTC) [abstract]. J Clin Oncol 2008;26:3522.
33. Sawada K, Radjabi AR, Shinomiya N, et al. c-Met overexpression is a prognostic factor in ovarian cancer and an effective target for inhibition of peritoneal dissemination and invasion. Cancer Res 2007;67:1670-9.
34. Ghoussoub RA, Dillon DA, D'Aquila T, Rimm EB, Fearon ER, Rimm DL. Expression of c-met is a strong independent prognostic factor in breast carcinoma. Cancer 1998;82:1513-20.
35. Kang JY, Dolled-Filhart M, Ocal IT, et al. Tissue microarray analysis of hepatocyte growth factor/Met pathway components reveals a role for Met, matriptase, and hepatocyte growth factor activator inhibitor 1 in the progression of node-negative breast cancer. Cancer Res 2003;63:1101-5.
36. Ren Y, Cao B, Law S, et al. Hepatocyte growth factor promotes cancer cell migration and angiogenic factors expression: a prognostic marker of human esophageal squamous cell carcinomas. Clin Cancer Res 2005;11:6190-7.
37. Srinivasan R, Choueiri TK, Vaishampayan U, et al. A phase II study of the dual MET/VEGFR2 inhibitor XL880 in patients (pts) with papillary renal carcinoma (PRC) [abstract]. J Clin Oncol 2008;26:5103.
38. Toi M, Taniguchi T, Ueno T, et al. Significance of circulating hepatocyte growth factor level as a prognostic indicator in primary breast cancer. Clin Cancer Res 1998;4:659-64.
39. Tuynman JB, Lagarde SM, Ten Kate FJ, Richel DJ, van Lanschot JJ. Met expression is an independent prognostic risk factor in patients with oesophageal adenocarcinoma. Br J Cancer 2008;98:1102-8.
40. Pena C, Shan M, Wilhelm S, Lathia C. Hepatocyte growth factor (HGF) is a prognostic biomarker for overall survival and a pharmacodynamic biomarker of sorafenib response in the SHARP phase III trial [abstract 460O]. Ann Oncol 2008;19:viii153-65.
41. Jun HT, Sun J, Rex K, et al. AMG 102, a fully human anti-hepatocyte growth factor/scatter factor neutralizing antibody, enhances the efficacy of temozolomide or docetaxel in U-87 MG cells and xenografts. Clin Cancer Res 2007;13:6735-42.
42. Rosen P, Sweeney C, Park D, et al. AMG 102, an HGF/SF antagonist, in combination with anti-angiogenesis targeted therapies in adult patients with advanced solid tumors [abstract]. J Clin Oncol 2008;26:3570.
43. Reardon D, Cloughsey T, Raizer J, et al. Phase II study of AMG 102, a fully human neutralizing antibody against hepatocyte growth factor/scatter factor, in patients with recurrent glioblastoma multiforme [abstract]. J Clin Oncol 2008;26:2051.