Phase I trial of weekly tigatuzumab, an agonistic humanized monoclonal antibody targeting death receptor 5 (DR5)

Cancer Biotherapy and Radiopharmaceuticals

Volumn 25, Issue 1, 2010, Pages 13-19

  Forero Torres, Andres ^a   Shah, Jatin ^a   Wood, Tina ^a   Posey, James ^a   Carlisle, Ronda ^a   Copigneaux, Catherine ^b   Luo, F ^b   Wojtowicz Praga, Slawomir ^b   Percent, Ivor ^a   Saleh, Mansoor ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b DAIICHI SANKYO INC   (United States)

Author keywords

Antibody; Apoptosis; Cancer; Immunotherapytargeted therapy

Indexed keywords

DEATH RECEPTOR 5; MONOCLONAL ANTIBODY; TIGATUZUMAB; UNCLASSIFIED DRUG; TUMOR NECROSIS FACTOR RELATED APOPTOSIS INDUCING LIGAND RECEPTOR;

ADULT; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BONE PAIN; CANCER RELAPSE; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; COUGHING; CROSS LINKING; CYTOTOXICITY; DECREASED APPETITE; DEPRESSION; DIARRHEA; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FEVER; FLUID RETENTION; HUMAN; IMMUNOGENICITY; LOWER ABDOMINAL PAIN; LUNG EMBOLISM; LYMPHOMA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NAUSEA; PARESTHESIA; PERIPHERAL EDEMA; PLEURA EFFUSION; PRIORITY JOURNAL; RASH; SIDE EFFECT; SINUS CONGESTION; SOLID TUMOR; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER ABDOMINAL PAIN; VOMITING; AGONISTS; CARCINOMA; DRUG EFFECTS; METABOLISM; MIDDLE AGED; PATHOLOGY; PHASE 1 CLINICAL TRIAL; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; APOPTOSIS; CARCINOMA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LYMPHOMA; MALE; MIDDLE AGED; RECEPTORS, TNF-RELATED APOPTOSIS-INDUCING LIGAND;

EID: 77649301860     PISSN: 10849785     EISSN: None     Source Type: Journal    
DOI: 10.1089/cbr.2009.0673     Document Type: Article

References (29)

1. Wiley SR, Schooley K, Smolak PJ, et al. Identification and characterization of a new member of the TNF family that induces apoptosis. Immunity 1995;3:673.
2. Daniel PT, Krammer PH. Activation induces sensitivity toward APO-1 (CD95)-mediated apoptosis in human B cells. J Immunol 1994;152:5624.
3. Buchsbaum DJ, Zhou T, Lobuglio AF. TRAIL receptor-targeted therapy. Future Oncol 2006;2:493.
4. de Vries EG, Gietema JA, de Jong S. Tumor necrosis factor-related apoptosis-inducing ligand pathway and its therapeutic implications. Clin Cancer Res 2006;12:2390.
5. Carlo-Stella C, Lavazza C, Locatelli A, et al. Targeting TRAIL agonistic receptors for cancer therapy. Clin Cancer Res 2007;13:2313.
6. Ashkenazi A, Pai RC, Fong S, et al. Safety and antitumor activity of recombinant soluble Apo2 ligand. J Clin Invest 1999;104:155.
7. Debatin KM. Apoptosis pathways in cancer and cancer therapy. Cancer Immunol Immunother 2004;53:153.
8. Chaudhary PM, Eby M, Jasmin A, et al. Death receptor 5, a new member of the TNFR family, and DR4 induce FADD-dependent apoptosis and activate the NF-kappaB pathway. Immunity 1997;7:821.
9. Tolcher AW, Mita M, Meropol NJ, et al. Phase I pharmaco-kinetic and biologic correlative study of mapatumumab, a fully human monoclonal antibody with agonist activity to tumor necrosis factor-related apoptosis-inducing ligand receptor-1. J Clin Oncol 2007;25:1390.
10. Rowinsky EK. Targeted induction of apoptosis in cancer management: The emerging role of tumor necrosis factor-related apoptosis-inducing ligand receptor activating agents. J Clin Oncol 2005;23:9394.
11. Ichikawa K, Liu W, Zhao L, et al. Tumoricidal activity of a novel anti-human DR5 monoclonal antibody without hepatocyte cytotoxicity. Nat Med 2001;7:954.
12. Buchsbaum DJ, Zhou T, Grizzle WE, et al. Antitumor efficacy of TRA-8 anti-DR5 monoclonal antibody alone or in combination with chemotherapy and=or radiation therapy in a human breast cancer model. Clin Cancer Res 2003;9: 3731.
13. DeRosier LC, Buchsbaum DJ, Oliver PG, et al. Combination treatment with TRA-8 antideath receptor 5 antibody and CPT-11 induces tumor regression in an orthotopic model of pancreatic cancer. Clin Cancer Res 2007;13:5535s.
14. Therasse P, Arbuck SG, Eisenhauer EA, et al. 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 2000;92:205.
15. Lister TA, Crowther D, Sutcliffe SB, et al. Report of a committee convened to discuss the evaluations and staging of patients with Hodgkin's disease: Cotswolds meeting. J Clin Oncol 1989;7:1630.
16. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999;17:1244.
17. Oliver PG, LoBuglio AF, Zinn KR, et al. Treatment of human cancer xenografts with TRA-8 anti-death receptor 5 antibody alone or in combination with CPT-11. Clin Cancer Res 2008;14:2180.
18. Derosier LC, Vickers SM, Zinn KR, et al. TRA-8 anti-DR5 monoclonal antibody and gemcitabine induce apoptosis and inhibit radiologically validated orthotopic pancreatic tumor growth. Mol Cancer Ther 2007;6:3198.
19. Long JW, Derosier LC, Vickers SM, et al. TRA-8 (TRAIL-R2 antibody)-based combination chemotherapy produces a survival benefit in a pancreatic cancer orthotopic model. J Surg Res 2007;137:167.
20. Estes JM, Oliver PG, Straughn JM, Jr., et al. Efficacy of anti-death receptor 5 (DR5) antibody (TRA-8) against primary human ovarian carcinoma using a novel ex vivo tissue slice model. Gynecol Oncol 2007;105:291.
21. Kendrick JE, Straughn JM, Jr., Oliver PG, et al. Anti-tumor activity of the TRA-8 anti-DR5 antibody in combination with cisplatin in an ex vivo human cervical cancer model. Gynecol Oncol 2008;108:591.
22. Kaliberov S, Stackhouse MA, Kaliberova L, et al. Enhanced apoptosis following treatment with TRA-8 anti-human DR5 monoclonal antibody and overexpression of exogenous Bax in human glioma cells. Gene Ther 2004;11:658.
23. Fiveash JB, Gillespie GY, Oliver PG, et al. Enhancement of glioma radiotherapy and chemotherapy response with targeted antibody therapy against death receptor 5. Int J Radiat Oncol Biol Phys 2008;71:507.
24. Plummer R, Attard D, Pacey S, et al. Phase 1 and pharmacokinetic study of Lexatumumab in patients with advanced cancers. Clin Cancer Res 2007;13:6187.
25. Adams C, Totpal K, Lawrence D, et al. Structural and functional analysis of the interaction between the agonistic monoclonal antibody, Apomab, and the proapoptotic receptor, DR5. Cell Death Differ 2008;15:751.
26. Li J, Tang B, Cheng J, et al. Antitumor efficacy of LBY135, an anti-DR5 monoclonal antibody, alone or in combination with chemotherapy in human colon tumor cell lines and xenografts. AACR Meeting Abstracts 2007; Abstract 4874.
27. Wang J, Lin Z, Qiao CX, et al. Characterization of a novel anti-DR5 monoclonal antibody WD1 with the potential to induce tumor cell apoptosis. Cell Mol Immunol 2008;5:55.
28. Wall J, Colloton M, Huard J, et al. AMG 655, a monoclonal antibody agonist directed against death receptor 5, induces apoptosis in human colon carcinoma cell lines and its therapeutic potential is enhanced in combination with chemo-therapeutic agents. AACR Meeting Abstracts 2008; Abstract 1326.
29. Kaplan-Lefko P, Bush T, Belmontes B, et al. AMG 655, a fully human agonistic antibody against death receptor 5, enhances the anti-tumor activity of gemcitabine in MiaPaCa2=T2, a pancreatic cancer model. AACR Meeting Abstracts 2008; Abstract 399.