A first-in-human, first-in-class, phase I study of carlumab (CNTO 888), a human monoclonal antibody against CC-chemokine ligand 2 in patients with solid tumors (original) (raw)

References

  1. Deshmane SL, Kremlev S, Amini S, Sawaya BE (2009) Monocyte chemoattractant protein-1 (MCP-1): an overview. J Interferon Cytokine Res 29(6):313–326. doi:10.1089/jir.2008.0027
    Article PubMed CAS Google Scholar
  2. Craig MJ, Loberg RD (2006) CCL2 (Monocyte Chemoattractant Protein-1) in cancer bone metastases. Cancer Metastasis Rev 25(4):611–619. doi:10.1007/s10555-006-9027-x
    Article PubMed CAS Google Scholar
  3. Lazennec G, Richmond A (2010) Chemokines and chemokine receptors: new insights into cancer-related inflammation. Trends Mol Med 16(3):133–144. doi:10.1016/j.molmed.2010.01.003
    Article PubMed CAS Google Scholar
  4. Qian BZ, Li J, Zhang H, Kitamura T, Zhang J, Campion LR, Kaiser EA, Snyder LA, Pollard JW (2011) CCL2 recruits inflammatory monocytes to facilitate breast-tumour metastasis. Nature 475(7355):222–225. doi:10.1038/nature10138
    Article PubMed CAS Google Scholar
  5. van Golen KL, Ying C, Sequeira L, Dubyk CW, Reisenberger T, Chinnaiyan AM, Pienta KJ, Loberg RD (2008) CCL2 induces prostate cancer transendothelial cell migration via activation of the small GTPase Rac. J Cell Biochem 104(5):1587–1597. doi:10.1002/jcb.21652
    Article PubMed Google Scholar
  6. Zhang J, Lu Y, Pienta KJ (2010) Multiple roles of chemokine (C–C motif) ligand 2 in promoting prostate cancer growth. J Natl Cancer Inst 102(8):522–528. doi:10.1093/jnci/djq044
    Article PubMed CAS Google Scholar
  7. Zhang J, Patel L, Pienta KJ (2010) CC chemokine ligand 2 (CCL2) promotes prostate cancer tumorigenesis and metastasis. Cytokine Growth Factor Rev 21(1):41–48. doi:10.1016/j.cytogfr.2009.11.009
    Article PubMed CAS Google Scholar
  8. Lu Y, Cai Z, Xiao G, Keller ET, Mizokami A, Yao Z, Roodman GD, Zhang J (2007) Monocyte chemotactic protein-1 mediates prostate cancer-induced bone resorption. Cancer Res 67(8):3646–3653. doi:10.1158/0008-5472.CAN-06-1210
    Article PubMed CAS Google Scholar
  9. Mizutani K, Sud S, McGregor NA, Martinovski G, Rice BT, Craig MJ, Varsos ZS, Roca H, Pienta KJ (2009) The chemokine CCL2 increases prostate tumor growth and bone metastasis through macrophage and osteoclast recruitment. Neoplasia 11(11):1235–1242
    PubMed CAS Google Scholar
  10. Roca H, Varsos Z, Pienta KJ (2008) CCL2 protects prostate cancer PC3 cells from autophagic death via phosphatidylinositol 3-kinase/AKT-dependent survivin up-regulation. J Biol Chem 283(36):25057–25073. doi:10.1074/jbc.M801073200
    Article PubMed CAS Google Scholar
  11. Sica A, Wang JM, Colotta F, Dejana E, Mantovani A, Oppenheim JJ, Larsen CG, Zachariae CO, Matsushima K (1990) Monocyte chemotactic and activating factor gene expression induced in endothelial cells by IL-1 and tumor necrosis factor. J Immunol 144(8):3034–3038
    PubMed CAS Google Scholar
  12. Arenberg DA, Keane MP, DiGiovine B, Kunkel SL, Strom SR, Burdick MD, Iannettoni MD, Strieter RM (2000) Macrophage infiltration in human non-small-cell lung cancer: the role of CC chemokines. Cancer Immunol Immunother 49(2):63–70
    Article PubMed CAS Google Scholar
  13. Hefler L, Tempfer C, Heinze G, Mayerhofer K, Breitenecker G, Leodolter S, Reinthaller A, Kainz C (1999) Monocyte chemoattractant protein-1 serum levels in ovarian cancer patients. Br J Cancer 81(5):855–859. doi:10.1038/sj.bjc.6690776
    Article PubMed CAS Google Scholar
  14. Koide N, Nishio A, Sato T, Sugiyama A, Miyagawa S (2004) Significance of macrophage chemoattractant protein-1 expression and macrophage infiltration in squamous cell carcinoma of the esophagus. Am J Gastroenterol 99(9):1667–1674. doi:10.1111/j.1572-0241.2004.30733.x
    Article PubMed CAS Google Scholar
  15. Loberg RD, Day LL, Harwood J, Ying C, St John LN, Giles R, Neeley CK, Pienta KJ (2006) CCL2 is a potent regulator of prostate cancer cell migration and proliferation. Neoplasia 8(7):578–586. doi:10.1593/neo.06280
    Article PubMed CAS Google Scholar
  16. Monti P, Leone BE, Marchesi F, Balzano G, Zerbi A, Scaltrini F, Pasquali C, Calori G, Pessi F, Sperti C, Di Carlo V, Allavena P, Piemonti L (2003) The CC chemokine MCP-1/CCL2 in pancreatic cancer progression: regulation of expression and potential mechanisms of antimalignant activity. Cancer Res 63(21):7451–7461
    PubMed CAS Google Scholar
  17. Ohta M, Kitadai Y, Tanaka S, Yoshihara M, Yasui W, Mukaida N, Haruma K, Chayama K (2002) Monocyte chemoattractant protein-1 expression correlates with macrophage infiltration and tumor vascularity in human esophageal squamous cell carcinomas. Int J Cancer 102(3):220–224. doi:10.1002/ijc.10705
    Article PubMed CAS Google Scholar
  18. Saji H, Koike M, Yamori T, Saji S, Seiki M, Matsushima K, Toi M (2001) Significant correlation of monocyte chemoattractant protein-1 expression with neovascularization and progression of breast carcinoma. Cancer 92(5):1085–1091. doi:10.1002/1097-0142(20010901)92:5<1085:AID-CNCR1424>3.0.CO;2-K
    Article PubMed CAS Google Scholar
  19. Ueno T, Toi M, Saji H, Muta M, Bando H, Kuroi K, Koike M, Inadera H, Matsushima K (2000) Significance of macrophage chemoattractant protein-1 in macrophage recruitment, angiogenesis, and survival in human breast cancer. Clin Cancer Res 6(8):3282–3289
    PubMed CAS Google Scholar
  20. Loberg RD, Ying C, Craig M, Yan L, Snyder LA, Pienta KJ (2007) CCL2 as an important mediator of prostate cancer growth in vivo through the regulation of macrophage infiltration. Neoplasia 9(7):556–562
    Article PubMed CAS Google Scholar
  21. Li X, Loberg R, Liao J, Ying C, Snyder LA, Pienta KJ, McCauley LK (2009) A destructive cascade mediated by CCL2 facilitates prostate cancer growth in bone. Cancer Res 69(4):1685–1692. doi:10.1158/0008-5472.CAN-08-2164
    Article PubMed CAS Google Scholar
  22. Loberg RD, Ying C, Craig M, Day LL, Sargent E, Neeley C, Wojno K, Snyder LA, Yan L, Pienta KJ (2007) Targeting CCL2 with systemic delivery of neutralizing antibodies induces prostate cancer tumor regression in vivo. Cancer Res 67(19):9417–9424. doi:10.1158/0008-5472.CAN-07-1286
    Article PubMed CAS Google Scholar
  23. Cancer Therapy Evaluation Program (August 9, 2006) Common Terminology Criteria for Adverse Events, Version 3.0. DCTD, NCI, NIH, DHH
  24. Le Tourneau C, Lee JJ, Siu LL (2009) Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst 101(10):708–720. doi:10.1093/jnci/djp079
    Article PubMed Google Scholar
  25. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines 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 92(3):205–216
    Article PubMed CAS Google Scholar
  26. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, Hussain M, Kaplan R, Myers C, Oh W, Petrylak DP, Reed E, Roth B, Sartor O, Scher H, Simons J, Sinibaldi V, Small EJ, Smith MR, Trump DL, Wilding G et al (1999) Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17(11):3461–3467
    PubMed CAS Google Scholar
  27. Rustin GJ, Quinn M, Thigpen T, du Bois A, Pujade-Lauraine E, Jakobsen A, Eisenhauer E, Sagae S, Greven K, Vergote I, Cervantes A, Vermorken J (2004) Re: new guidelines to evaluate the response to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst 96(6):487–488
    Article PubMed Google Scholar
  28. Danila DC, Heller G, Gignac GA, Gonzalez-Espinoza R, Anand A, Tanaka E, Lilja H, Schwartz L, Larson S, Fleisher M, Scher HI (2007) Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res 13(23):7053–7058. doi:10.1158/1078-0432.CCR-07-1506
    Article PubMed CAS Google Scholar
  29. de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D (2008) Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 14(19):6302–6309. doi:10.1158/1078-0432.CCR-08-0872
    Article PubMed Google Scholar
  30. Fetterly GJ, Aras U, Zagst PD, Takimoto CH, Mager DE, Seetharam S, McIntosh T, De Bono JS, Tolcher AW, Davis HM, Zhou HZ, Puchalski TA (2012) Utilizing mechanistic PK/PD modeling to simultaneously examine free CCL2, total CCL2 and carlumab (CNTO888) serum concentration time data (manuscript submitted for publication). Clin Cancer Res
  31. Messiou C, Orton M, Ang JE, Collins DJ, Morgan VA, Mears D, Castellano I, Papadatos-Pastos D, Brunetto A, Tunariu N, Mann H, Tessier J, Young H, Ghiorghiu D, Marley S, Kaye SB, deBono JS, Leach MO, deSouza NM (2012) Comparison of DCE MRI and CT as markers of vascular activity in advanced solid tumors treated with cediranib. Radiology
  32. Ishida T, Joh T, Uike N, Yamamoto K, Utsunomiya A, Yoshida S, Saburi Y, Miyamoto T, Takemoto S, Suzushima H, Tsukasaki K, Nosaka K, Fujiwara H, Ishitsuka K, Inagaki H, Ogura M, Akinaga S, Tomonaga M, Tobinai K, Ueda R (2012) Defucosylated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study. J Clin Oncol 30(8):837–842. doi:10.1200/JCO.2011.37.3472
    Article PubMed CAS Google Scholar
  33. Yamamoto K, Utsunomiya A, Tobinai K, Tsukasaki K, Uike N, Uozumi K, Yamaguchi K, Yamada Y, Hanada S, Tamura K, Nakamura S, Inagaki H, Ohshima K, Kiyoi H, Ishida T, Matsushima K, Akinaga S, Ogura M, Tomonaga M, Ueda R (2010) Phase I study of KW-0761, a defucosylated humanized anti-CCR4 antibody, in relapsed patients with adult T-cell leukemia-lymphoma and peripheral T-cell lymphoma. J Clin Oncol 28(9):1591–1598. doi:10.1200/JCO.2009.25.3575
    Article PubMed CAS Google Scholar
  34. Haringman JJ, Gerlag DM, Smeets TJ, Baeten D, van den Bosch F, Bresnihan B, Breedveld FC, Dinant HJ, Legay F, Gram H, Loetscher P, Schmouder R, Woodworth T, Tak PP (2006) A randomized controlled trial with an anti-CCL2 (anti-monocyte chemotactic protein 1) monoclonal antibody in patients with rheumatoid arthritis. Arthritis Rheum 54(8):2387–2392. doi:10.1002/art.21975
    Article PubMed CAS Google Scholar
  35. Vergunst CE, Gerlag DM, Lopatinskaya L, Klareskog L, Smith MD, van den Bosch F, Dinant HJ, Lee Y, Wyant T, Jacobson EW, Baeten D, Tak PP (2008) Modulation of CCR2 in rheumatoid arthritis: a double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum 58(7):1931–1939. doi:10.1002/art.23591
    Article PubMed CAS Google Scholar
  36. Puchalski T, Han C, McIntosh T, Brenner E, Fink D, Graham K, Jiao Q, Seetharam S, Takimoto C, Davis H, Zhou HZ (2012) A novel preclinical study in cynomolgus monkeys examining CCL2 production rate and kinetic profile after escalating dose administration of anti-CCL2 human monoclonal antibody carlumab (CNTO 888). Paper presented at the AACR, Chicago, IL

Download references