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Volumn 85, Issue 3, 2009, Pages 247-258

Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies

Author keywords

[No Author keywords available]

Indexed keywords

CYTOKINE; METHOTREXATE; MONOCLONAL ANTIBODY; TGN 1412; TRASTUZUMAB;

EID: 60349087476     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.273     Document Type: Review
Times cited : (95)

References (50)
  • 1
    • 55249123170 scopus 로고    scopus 로고
    • CTLA-4: Negative regulator of the immune response and a target for cancer therapy
    • Keilholz, U. CTLA-4: negative regulator of the immune response and a target for cancer therapy. J. Immunother. 31, 431-439 (2008).
    • (2008) J. Immunother , vol.31 , pp. 431-439
    • Keilholz, U.1
  • 3
    • 40849085424 scopus 로고    scopus 로고
    • The effects of antibody treatment on regulatory CD4(+)CD25(+) T cells
    • Yi, H., Zhang, J. & Zhao, Y. The effects of antibody treatment on regulatory CD4(+)CD25(+) T cells. Transpl. Immunol. 19, 37-44 (2008).
    • (2008) Transpl. Immunol , vol.19 , pp. 37-44
    • Yi, H.1    Zhang, J.2    Zhao, Y.3
  • 4
    • 34447091994 scopus 로고    scopus 로고
    • Preclinical and clinical safety of monoclonal antibodies
    • Tabrizi, M.A. & Roskos, L.K. Preclinical and clinical safety of monoclonal antibodies. Drug Discov. Today 12, 540-547 (2007).
    • (2007) Drug Discov. Today , vol.12 , pp. 540-547
    • Tabrizi, M.A.1    Roskos, L.K.2
  • 5
    • 33748416499 scopus 로고    scopus 로고
    • Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412
    • Suntharalingam, G. et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355, 1018-1028 (2006).
    • (2006) N. Engl. J. Med , vol.355 , pp. 1018-1028
    • Suntharalingam, G.1
  • 6
    • 37349072460 scopus 로고    scopus 로고
    • Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis
    • Yang, J.C. et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J. Immunother. 30, 825-830 (2007).
    • (2007) J. Immunother , vol.30 , pp. 825-830
    • Yang, J.C.1
  • 7
    • 60349088886 scopus 로고    scopus 로고
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. 〈http://www.ich.org/LOB/media/MEDIA503.pdf〉 (1997).
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. 〈http://www.ich.org/LOB/media/MEDIA503.pdf〉 (1997).
  • 8
    • 8844220589 scopus 로고    scopus 로고
    • Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody
    • Clarke, J. et al. Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody. Regul. Toxicol. Pharmacol. 40, 219-226 (2004).
    • (2004) Regul. Toxicol. Pharmacol , vol.40 , pp. 219-226
    • Clarke, J.1
  • 9
    • 0033916950 scopus 로고    scopus 로고
    • Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody
    • Treacy, G. Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody. Hum. Exp. Toxicol. 19, 226-228 (2000).
    • (2000) Hum. Exp. Toxicol , vol.19 , pp. 226-228
    • Treacy, G.1
  • 10
    • 20944442212 scopus 로고    scopus 로고
    • STP position paper: Best practice guideline for the routine pathology evaluation of the immune system
    • discussion 408
    • Haley, P. et al. STP position paper: best practice guideline for the routine pathology evaluation of the immune system. Toxicol. Pathol. 33, 404-407; discussion 408 (2005).
    • (2005) Toxicol. Pathol , vol.33 , pp. 404-407
    • Haley, P.1
  • 11
    • 60349106367 scopus 로고    scopus 로고
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S8: Immunotoxicity Studies for Human Pharmaceuticals. 〈http://www.ich.org/LOB/media/MEDIA1706.pdf〉 (2005).
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S8: Immunotoxicity Studies for Human Pharmaceuticals. 〈http://www.ich.org/LOB/media/MEDIA1706.pdf〉 (2005).
  • 14
    • 48149092512 scopus 로고    scopus 로고
    • Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics
    • Vargas, H.M. et al. Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J. Pharmacol. Toxicol. Methods 58, 72-76 (2008).
    • (2008) J. Pharmacol. Toxicol. Methods , vol.58 , pp. 72-76
    • Vargas, H.M.1
  • 16
    • 60349087948 scopus 로고    scopus 로고
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. 〈http://www.fda.gov/cder/Guidance/5541fnl.pdf〉 (2005).
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. 〈http://www.fda.gov/cder/Guidance/5541fnl.pdf〉 (2005).
  • 17
    • 60349093939 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products. 〈http://www.emea. europa.eu/pdfs/human/swp/2836707enfin.pdf〉 (2007).
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products. 〈http://www.emea. europa.eu/pdfs/human/swp/2836707enfin.pdf〉 (2007).
  • 18
    • 60349099864 scopus 로고    scopus 로고
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals (draft, step 2). 〈http://www.ich.org/LOB/media/MEDIA1706.pdf〉 (2008).
    • International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals (draft, step 2). 〈http://www.ich.org/LOB/media/MEDIA1706.pdf〉 (2008).
  • 20
    • 21644463169 scopus 로고    scopus 로고
    • Siglecs in innate immunity
    • Crocker, P.R. Siglecs in innate immunity. Curr. Opin. Pharmacol. 5, 431-437 (2005).
    • (2005) Curr. Opin. Pharmacol , vol.5 , pp. 431-437
    • Crocker, P.R.1
  • 21
    • 33748515685 scopus 로고    scopus 로고
    • Fc receptor III homologues in nonhuman primate species: Genetic characterization and ligand interactions
    • Rogers, K.A., Scinicariello, F. & Attanasio, R. IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions. J. Immunol. 177, 3848-3856 (2006).
    • (2006) J. Immunol , vol.177 , pp. 3848-3856
    • Rogers, K.A.1    Scinicariello, F.2    Attanasio, R.I.3
  • 22
    • 34748865088 scopus 로고    scopus 로고
    • Antibody therapeutics: Isotype and glycoform selection
    • Jefferis, R. Antibody therapeutics: isotype and glycoform selection. Expert Opin. Biol. Ther. 7, 1401-1413 (2007).
    • (2007) Expert Opin. Biol. Ther , vol.7 , pp. 1401-1413
    • Jefferis, R.1
  • 23
    • 0036844423 scopus 로고    scopus 로고
    • Complement activation is responsible for acute toxicities in rhesus monkeys treated with a phosphorothioate oligodeoxynucleotide
    • Henry, S.P. et al. Complement activation is responsible for acute toxicities in rhesus monkeys treated with a phosphorothioate oligodeoxynucleotide. Int. Immunopharmacol. 2, 1657-1666 (2002).
    • (2002) Int. Immunopharmacol , vol.2 , pp. 1657-1666
    • Henry, S.P.1
  • 24
    • 40549112339 scopus 로고    scopus 로고
    • Studies of monkey complement: Measurement of cynomolgus monkey CH50, ACH50, C4, C2 and C3
    • Xu, H. et al. Studies of monkey complement: measurement of cynomolgus monkey CH50, ACH50, C4, C2 and C3. Xenotransplantation 15, 14-19 (2008).
    • (2008) Xenotransplantation , vol.15 , pp. 14-19
    • Xu, H.1
  • 25
    • 0034655265 scopus 로고    scopus 로고
    • Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc
    • Idusogie, E.E. et al. Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc. J. Immunol. 164, 4178-4184 (2000).
    • (2000) J. Immunol , vol.164 , pp. 4178-4184
    • Idusogie, E.E.1
  • 26
    • 35648954031 scopus 로고    scopus 로고
    • Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer - identification, prevention, and management
    • Kang, S.P. & Saif, M.W. Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer - identification, prevention, and management. J. Support Oncol. 5, 451-457 (2007).
    • (2007) J. Support Oncol , vol.5 , pp. 451-457
    • Kang, S.P.1    Saif, M.W.2
  • 29
    • 38349175425 scopus 로고    scopus 로고
    • High-risk molecules or insufficient scientific data?
    • Mignot, A. High-risk molecules or insufficient scientific data? Clin. Pharmacol. Ther. 83, 365-367 (2008).
    • (2008) Clin. Pharmacol. Ther , vol.83 , pp. 365-367
    • Mignot, A.1
  • 30
    • 0032521303 scopus 로고    scopus 로고
    • Humanized IgG1 and IgG4 anti-CD4 monoclonal antibodies: Effects on lymphocytes in the blood, lymph nodes, and renal allografts in cynomolgus monkeys
    • Mourad, G.J. et al. Humanized IgG1 and IgG4 anti-CD4 monoclonal antibodies: effects on lymphocytes in the blood, lymph nodes, and renal allografts in cynomolgus monkeys. Transplantation 65, 632-641 (1998).
    • (1998) Transplantation , vol.65 , pp. 632-641
    • Mourad, G.J.1
  • 31
    • 33845486708 scopus 로고    scopus 로고
    • Wise, M.P., Gallimore, A. & Godkin, A. T-cell costimulation. N. Engl. J. Med. 355, 2594-2595; author reply 2595 (2006).
    • Wise, M.P., Gallimore, A. & Godkin, A. T-cell costimulation. N. Engl. J. Med. 355, 2594-2595; author reply 2595 (2006).
  • 32
    • 0036179603 scopus 로고    scopus 로고
    • Trastuzumab: A review of its use in the treatment of metastatic breast cancer overexpressing HER2
    • McKeage, K. & Perry, C.M. Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs 62, 209-243 (2002).
    • (2002) Drugs , vol.62 , pp. 209-243
    • McKeage, K.1    Perry, C.M.2
  • 33
    • 34548229364 scopus 로고    scopus 로고
    • FcRn: The neonatal Fc receptor comes of age
    • Roopenian, D.C. & Akilesh, S. FcRn: the neonatal Fc receptor comes of age. Nat. Rev. Immunol. 7, 715-725 (2007).
    • (2007) Nat. Rev. Immunol , vol.7 , pp. 715-725
    • Roopenian, D.C.1    Akilesh, S.2
  • 34
    • 32444438731 scopus 로고    scopus 로고
    • Elimination mechanisms of therapeutic monoclonal antibodies
    • Tabrizi, M.A., Tseng, C.M. & Roskos, L.K. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today 11, 81-88 (2006).
    • (2006) Drug Discov. Today , vol.11 , pp. 81-88
    • Tabrizi, M.A.1    Tseng, C.M.2    Roskos, L.K.3
  • 35
    • 35648945837 scopus 로고    scopus 로고
    • On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development
    • Lowe, P.J., Hijazi, Y., Luttringer, O., Yin, H., Sarangapani, R. & Howard, D. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica 37, 1331-1354 (2007).
    • (2007) Xenobiotica , vol.37 , pp. 1331-1354
    • Lowe, P.J.1    Hijazi, Y.2    Luttringer, O.3    Yin, H.4    Sarangapani, R.5    Howard, D.6
  • 36
    • 43049154225 scopus 로고    scopus 로고
    • Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies
    • Waibler, Z. et al. Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies. PLoS ONE 3, e1708 (2008).
    • (2008) PLoS ONE , vol.3
    • Waibler, Z.1
  • 37
    • 60349103954 scopus 로고    scopus 로고
    • TeGenero. Investigator's Brochure. TGN1412 Humanized Agonistic Anti-CD28 Monoclonal Antibody, edition 1.1. 〈http://www.circare.org/foia5/ tgn1412investigatorbrochure.pdf〉 (2005).
    • TeGenero. Investigator's Brochure. TGN1412 Humanized Agonistic Anti-CD28 Monoclonal Antibody, edition 1.1. 〈http://www.circare.org/foia5/ tgn1412investigatorbrochure.pdf〉 (2005).
  • 38
    • 37749032491 scopus 로고    scopus 로고
    • Cytokine storm in the phase I trial of monoclonal antibody TGN1412: Better understanding the causes to improve preclinical testing of immunotherapeutics
    • Stebbings, R. et al. "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J. Immunol. 179, 3325-3331 (2007).
    • (2007) J. Immunol , vol.179 , pp. 3325-3331
    • Stebbings, R.1
  • 39
    • 43049183119 scopus 로고    scopus 로고
    • CD28 superagonists: What makes the difference in humans?
    • Schraven, B. & Kalinke, U. CD28 superagonists: what makes the difference in humans? Immunity 28, 591-595 (2008).
    • (2008) Immunity , vol.28 , pp. 591-595
    • Schraven, B.1    Kalinke, U.2
  • 40
    • 38349095115 scopus 로고    scopus 로고
    • Innovative early development regulatory approaches: ExpIND, expCTA, microdosing
    • Robinson, W.T. Innovative early development regulatory approaches: expIND, expCTA, microdosing. Clin. Pharmacol. Ther. 83, 358-360 (2008).
    • (2008) Clin. Pharmacol. Ther , vol.83 , pp. 358-360
    • Robinson, W.T.1
  • 41
    • 60349084327 scopus 로고    scopus 로고
    • Federal Agency for Medicines and Health Products
    • Federal Agency for Medicines and Health Products. Guidance to the Conduct of Exploratory Trials in Belgium. 〈http://www.ahppi.org.uk/CMS/STORE/ Guidance&PositionPaper/Guidance-exploratorytrials-files/ATTACHMENTS/ EXPLORATORY-GUIDELINE.doc〉 (2007).
    • (2007) Guidance to the Conduct of Exploratory Trials in Belgium
  • 42
    • 60349086155 scopus 로고    scopus 로고
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry, Investigators, and Reviewers: Exploratory IND studies. 〈http://www.fda.gov/cder/guidance/7086fnl.pdf〉 (2006).
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry, Investigators, and Reviewers: Exploratory IND studies. 〈http://www.fda.gov/cder/guidance/7086fnl.pdf〉 (2006).
  • 43
    • 60349089918 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose. 〈http://www.emea.europa.eu/pdfs/human/swp/ 259902en.pdf〉 (2004).
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose. 〈http://www.emea.europa.eu/pdfs/human/swp/ 259902en.pdf〉 (2004).
  • 44
    • 0037083403 scopus 로고    scopus 로고
    • Idiotypic-anti-idiotypic complexes and their in vivo metabolism
    • 2002
    • Johansson, A. et al. Idiotypic-anti-idiotypic complexes and their in vivo metabolism. Cancer 94 (4 suppl.),1306-1313 (2002).
    • Cancer , vol.94 , Issue.4 SUPPL. , pp. 1306-1313
    • Johansson, A.1
  • 45
    • 34249684926 scopus 로고    scopus 로고
    • A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
    • Shankar, G., Pendley, C. & Stein, K.E. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 25, 555-561 (2007).
    • (2007) Nat. Biotechnol , vol.25 , pp. 555-561
    • Shankar, G.1    Pendley, C.2    Stein, K.E.3
  • 47
    • 3142534409 scopus 로고    scopus 로고
    • Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    • Mire-Sluis, A.R. et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289, 1-16 (2004).
    • (2004) J. Immunol. Methods , vol.289 , pp. 1-16
    • Mire-Sluis, A.R.1
  • 48
    • 34548861488 scopus 로고    scopus 로고
    • An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug
    • Bourdage, J.S., Cook, C.A., Farrington, D.L., Chain, J.S. & Konrad, R.J. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J. Immunol. Methods 327, 10-17 (2007).
    • (2007) J. Immunol. Methods , vol.327 , pp. 10-17
    • Bourdage, J.S.1    Cook, C.A.2    Farrington, D.L.3    Chain, J.S.4    Konrad, R.J.5
  • 49
    • 33750608522 scopus 로고    scopus 로고
    • Lessons from TGN1412
    • author reply 1570
    • Hanke, T. Lessons from TGN1412. Lancet 368, 1569-1570; author reply 1570 (2006).
    • (2006) Lancet , vol.368 , pp. 1569-1570
    • Hanke, T.1
  • 50
    • 55549108671 scopus 로고    scopus 로고
    • Toward experimental assessment of receptor occupancy: TGN1412 revisited
    • Waibler, Z. et al. Toward experimental assessment of receptor occupancy: TGN1412 revisited. J. Allergy Clin. Immunol. 122, 890-892 (2008).
    • (2008) J. Allergy Clin. Immunol , vol.122 , pp. 890-892
    • Waibler, Z.1


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