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

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 4, 2013, Pages 1041-1050

  Sandhu, Shahneen K ^a   Papadopoulos, Kyri ^b   Fong, Peter C ^a   Patnaik, Amita ^b   Messiou, Christina ^a   Olmos, David ^a   Wang, George ^c   Tromp, Brenda J ^d   Puchalski, Thomas A ^c   Balkwill, Frances ^e   Berns, Birge ^f   Seetharam, Shobha ^c   De Bono, Johann S ^a   Tolcher, Anthony W ^b  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b START Center for Cancer Care   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d Janssen Biologics   (Netherlands)

^e QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^f Global Regulatory Affairs   (United Kingdom)

Author keywords

Carlumab; CC chemokine ligand 2; CC chemokine receptor 2; Phase I; Solid tumors

Indexed keywords

CARLUMAB; MONOCYTE CHEMOTACTIC PROTEIN 1; PROSTATE SPECIFIC ANTIGEN; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ADVANCED CANCER; ADVERSE OUTCOME; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CHILL; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COGNITIVE DEFECT; DECREASED APPETITE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN TISSUE; HYPERTRANSAMINASEMIA; IMMUNOGENICITY; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OVARY CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; PRURITUS; SOLID TUMOR; VASCULITIC RASH; VOMITING; DRUG ANTAGONISM; MIDDLE AGED; NEOPLASM; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CHEMOKINE CCL2; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS;

MLCS; MLOWN;

EID: 84878849941     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2099-8     Document Type: Article

References (36)

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
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 (Pubitemid 46071867)
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
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
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
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
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
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 (Pubitemid 46762149)
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
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
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 (Pubitemid 20149476)
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 (Pubitemid 30431641)
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 (Pubitemid 29504697)
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 (Pubitemid 39237489)
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 (Pubitemid 44061313)
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 (Pubitemid 37413488)
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 (Pubitemid 35222287)
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 (Pubitemid 32861655)
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 (Pubitemid 30637758)
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 (Pubitemid 47121829)
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
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 (Pubitemid 47535932)
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
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
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 (Pubitemid 29517916)
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 (Pubitemid 38443654)
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 (Pubitemid 350276887)
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
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
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
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 (Pubitemid 44204998)
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 (Pubitemid 351988084)
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