Death receptor 5 agonistic antibody PRO95780: preclinical pharmacokinetics and concentration-effect relationship support clinical dose and regimen selection.
作者： Hong Xiang , Arthur E. Reyes , Steve Eppler , Sean Kelley , Lisa A. Damico-Beyer
DOI: 10.1007/S00280-013-2200-3
关键词: Monoclonal 、 Pharmacology 、 Regimen 、 Cancer 、 Antibody 、 Monoclonal antibody 、 Medicine 、 PK/PD models 、 Pharmacokinetics 、 Clinical trial
摘要: Purpose PRO95780, a human monoclonal antibody (mAb) against death receptor 5 (DR5/TRAIL-R2/TNFRSF10B), was developed for the treatment cancer. Our objective to characterize pharmacokinetics (PK) in mice, rats, and cynomolgus monkeys concentration–effect relationships of PRO95780 xenograft mouse models cancers; this would guide selection dose regimen clinical trials.
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Rong Deng, Suhasini Iyer, Frank-Peter Theil, Deborah L. Mortensen, Paul J. Fielder, Saileta Prabhu, Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? mAbs. ,vol. 3, pp. 61- 66 ,(2011) , 10.4161/MABS.3.1.13799
Laura DeForge, Jeanine Bussiere, Judith A. Fox, Klara Totpal, Sean K. Kelley, David Xie, Louise A. Harris, Preclinical Studies to Predict the Disposition of Apo2L/Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand in Humans: Characterization of in Vivo Efficacy, Pharmacokinetics, and Safety Journal of Pharmacology and Experimental Therapeutics. ,vol. 299, pp. 31- 38 ,(2001)
Iftekhar Mahmood, Interspecies scaling of protein drugs: prediction of clearance from animals to humans. Journal of Pharmaceutical Sciences. ,vol. 93, pp. 177- 185 ,(2004) , 10.1002/JPS.10531
Pascal Schneider, Margot Thome, Kim Burns, Jean-Luc Bodmer, Kay Hofmann, Takao Kataoka, Nils Holler, Jürg Tschopp, TRAIL Receptors 1 (DR4) and 2 (DR5) Signal FADD-Dependent Apoptosis and Activate NF-κB Immunity. ,vol. 7, pp. 831- 836 ,(1997) , 10.1016/S1074-7613(00)80401-X
Thomas S Griffith, David H Lynch, TRAIL: a molecule with multiple receptors and control mechanisms Current Opinion in Immunology. ,vol. 10, pp. 559- 563 ,(1998) , 10.1016/S0952-7915(98)80224-0
Preet M Chaudhary, Michael Eby, Alan Jasmin, Angela Bookwalter, Jessica Murray, Leroy Hood, Death Receptor 5, a New Member of the TNFR Family, and DR4 Induce FADD-Dependent Apoptosis and Activate the NF-κB Pathway Immunity. ,vol. 7, pp. 821- 830 ,(1997) , 10.1016/S1074-7613(00)80400-8
Nelson L Jumbe, Yan Xin, Douglas D Leipold, Lisa Crocker, Debra Dugger, Elaine Mai, Mark X Sliwkowski, Paul J Fielder, Jay Tibbitts, None, Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice. Journal of Pharmacokinetics and Pharmacodynamics. ,vol. 37, pp. 221- 242 ,(2010) , 10.1007/S10928-010-9156-2
Camellia W. Adams, David E. Allison, Kelly Flagella, Leonard Presta, Janet Clarke, Noel Dybdal, Kathleen McKeever, Mark X. Sliwkowski, Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunology, Immunotherapy. ,vol. 55, pp. 717- 727 ,(2006) , 10.1007/S00262-005-0058-X
Mariapia A. Degli-Esposti, Pamela J. Smolak, Henning Walczak, Jennifer Waugh, Chang-Pin Huang, Robert F. DuBose, Raymond G. Goodwin, Craig A. Smith, Cloning and characterization of TRAIL-R3, a novel member of the emerging TRAIL receptor family. Journal of Experimental Medicine. ,vol. 186, pp. 1165- 1170 ,(1997) , 10.1084/JEM.186.7.1165
Jie Ling, Honghui Zhou, Qun Jiao, Hugh M. Davis, Interspecies scaling of therapeutic monoclonal antibodies: initial look. The Journal of Clinical Pharmacology. ,vol. 49, pp. 1382- 1402 ,(2009) , 10.1177/0091270009337134