A phase 1 study of ABT-806 in subjects with advanced solid tumors

Investigational New Drugs

Volumn 33, Issue 3, 2015, Pages 671-678

  Cleary, James M ^a,b   Reardon, David A ^a,b   Azad, Nilofer ^c   Gandhi, Leena ^a,b   Shapiro, Geoffrey I ^a,b   Chaves, Jorge ^d   Pedersen, Michelle ^e   Ansell, Peter ^e   Ames, William ^e   Xiong, Hao ^e   Munasinghe, Wijith ^e   Dudley, Matt ^e   Reilly, Edward B ^e   Holen, Kyle ^e   Humerickhouse, Rod ^e  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d Northwest Medical Specialties   (United States)

^e ABBVIE INC   (United States)

Author keywords

EGFR; EGFRvIII; Glioblastoma; Solid tumors

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY 806; TUMOR MARKER;

ADULT; AGED; AREA UNDER THE CURVE; CANCER STAGING; CLINICAL TRIAL; COHORT ANALYSIS; DOSE RESPONSE; FEMALE; HUMAN; MALE; METABOLISM; MIDDLE AGED; NEOPLASMS; PATHOLOGY; PHASE 1 CLINICAL TRIAL; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; AREA UNDER CURVE; BIOMARKERS, TUMOR; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASMS; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84937759445     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-015-0234-6     Document Type: Article

References (33)

1. Krause DS, Van Etten RA (2005) Tyrosine kinases as targets for cancer therapy. N Engl J Med 353:172-187
2. Ciardiello F, Tortora G (2008) EGFR antagonists in cancer treatment. N Engl J Med 358:1160-1174
3. Wong RW (2003) Transgenic and knock-out mice for deciphering the roles of EGFR ligands. Cell Mol Life Sci 60:113-118
4. Bonner JA, Raisch KP, Trummell HQ, Robert F, Meredith RF, Spencer SA, Buchsbaum DJ, Saleh MN, Stackhouse MA, LoBuglio AF, Peters GE, Carroll WR, Waksal HW (2000) Enhanced apoptosis with combination C225/radiation treatment serves as the impetus for clinical investigation in head and neck cancers. J Clin Oncol 18:47S-53S
5. Baselga J, Mendelsohn J (1994) The epidermal growth factor receptor as a target for therapy in breast carcinoma. Breast Cancer Res Treat 29:127-138
6. Frederick L, Wang XY, Eley G, James CD (2000) Diversity and frequency of epidermal growth factor receptor mutations in human glioblastomas. Cancer Res 60:1383-1387
7. Sugawa N, Ekstrand AJ, James CD, Collins VP (1990) Identical splicing of aberrant epidermal growth factor receptor transcripts from amplified rearranged genes in human glioblastomas. Proc Natl Acad Sci U S A 87:8602-8606
8. Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, Canon JL, Van Laethem JL, Maurel J, Richardson G, Wolf M, Amado RG (2007) Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 25:1658-1664
9. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ (2007) Cetuximab for the treatment of colorectal cancer. N Engl J Med 357:2040-2048
10. Boone SL, Rademaker A, Liu D, Pfeiffer C, Mauro DJ, Lacouture ME (2007) Impact and management of skin toxicity associated with anti-epidermal growth factor receptor therapy: survey results. Oncology 72:152-159
11. Albanell J, Codony-Servat J, Rojo F, Del Campo JM, Sauleda S, Anido J, Raspall G, Giralt J, Rosello J, Nicholson RI, Mendelsohn J, Baselga J (2001) Activated extracellular signal-regulated kinases: association with epidermal growth factor receptor/transforming growth factor alpha expression in head and neck squamous carcinoma and inhibition by anti-epidermal growth factor receptor treatments. Cancer Res 61:6500-6510
12. Huang SM, Bock JM, Harari PM (1999) Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res 59:1935-1940
13. Thomas SM, Grandis JR (2004) Pharmacokinetic and pharmacodynamic properties of EGFR inhibitors under clinical investigation. Cancer Treat Rev 30:255-268
14. Gan HK, Burgess AW, Clayton AH, Scott AM (2012) Targeting of a conformationally exposed, tumor-specific epitope of EGFR as a strategy for cancer therapy. Cancer Res 72:2924-2930
15. Luwor RB, Johns TG, Murone C, Huang HJ, Cavenee WK, Ritter G, Old LJ, Burgess AW, Scott AM (2001) Monoclonal antibody 806 inhibits the growth of tumor xenografts expressing either the de2-7 or amplified epidermal growth factor receptor (EGFR) but not wild-type EGFR. Cancer Res 61:5355-5361
16. Li D, Ji H, Zaghlul S, McNamara K, Liang MC, Shimamura T, Kubo S, Takahashi M, Chirieac LR, Padera RF, Scott AM, Jungbluth AA, Cavenee WK, Old LJ, Demetri GD, Wong KK (2007) Therapeutic anti-EGFR antibody 806 generates responses in murine de novo EGFR mutant-dependent lung carcinomas. J Clin Invest 117:346-352
17. Mishima K, Johns TG, Luwor RB, Scott AM, Stockert E, Jungbluth AA, Ji XD, Suvarna P, Voland JR, Old LJ, Huang HJ, Cavenee WK (2001) Growth suppression of intracranial xenografted glioblastomas overexpressing mutant epidermal growth factor receptors by systemic administration of monoclonal antibody (mAb) 806, a novel monoclonal antibody directed to the receptor. Cancer Res 61:5349-5354
18. Scott AM, Lee FT, Tebbutt N, Herbertson R, Gill SS, Liu Z, Skrinos E, Murone C, Saunder TH, Chappell B, Papenfuss AT, Poon AM, Hopkins W, Smyth FE, MacGregor D, Cher LM, Jungbluth AA, Ritter G, Brechbiel MW, Murphy R, Burgess AW, Hoffman EW, Johns TG, Old LJ (2007) A phase I clinical trial with monoclonal antibody ch806 targeting transitional state and mutant epidermal growth factor receptors. Proc Natl Acad Sci U S A 104:4071-4076
19. Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ (2012) EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 13:33-42
20. Panousis C, Rayzman VM, Johns TG, Renner C, Liu Z, Cartwright G, Lee FT, Wang D, Gan H, Cao D, Kypridis A, Smyth FE, Brechbiel MW, Burgess AW, Old LJ, Scott AM (2005) Engineering and characterisation of chimeric monoclonal antibody 806 (ch806) for targeted immunotherapy of tumours expressing de2-7 EGFR or amplified EGFR. Br J Cancer 92:1069-1077
21. Erbitux (cetuximab) [package insert] (2013) Indianapolis, IN: Eli Lilly
22. Tan AR, Moore DF, Hidalgo M, Doroshow JH, Poplin EA, Goodin S, Mauro D, Rubin EH (2006) Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin Cancer Res 12:6517-6522
23. Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D'Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J (2000) Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J Clin Oncol 18:904-914
24. Rowinsky EK, Schwartz GH, Gollob JA, Thompson JA, Vogelzang NJ, Figlin R, Bukowski R, Haas N, Lockbaum P, Li YP, Arends R, Foon KA, Schwab G, Dutcher J (2004) Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol 22:3003-3015
25. Hatanpaa KJ, Burma S, Zhao D, Habib AA (2010) Epidermal growth factor receptor in glioma: signal transduction, neuropathology, imaging, and radioresistance. Neoplasia 12:675-684
26. Snuderl M, Fazlollahi L, Le LP, Nitta M, Zhelyazkova BH, Davidson CJ, Akhavanfard S, Cahill DP, Aldape KD, Betensky RA, Louis DN, Iafrate AJ (2011) Mosaic amplification of multiple receptor tyrosine kinase genes in glioblastoma. Cancer Cell 20:810-817
27. Yasuda H, Kobayashi S, Costa DB (2012) EGFR exon 20 insertion mutations in non-small-cell lung cancer: preclinical data and clinical implications. Lancet Oncol 13:e23-e31
28. Yasuda H, Park E, Yun CH, Sng NJ, Lucena-Araujo AR, Yeo WL, Huberman MS, Cohen DW, Nakayama S, Ishioka K, Yamaguchi N, Hanna M, Oxnard GR, Lathan CS, Moran T, Sequist LV, Chaft JE, Riely GJ, Arcila ME, Soo RA, Meyerson M, Eck MJ, Kobayashi SS, Costa DB (2013) Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer. Sci Transl Med 5:216ra177
29. Men HT, Gou HF, Qiu M, He JP, Cheng K, Chen Y, Ge J, Liu JY (2014) A case of penile squamous cell carcinoma treated with a combination of antiepidermal growth factor receptor antibody and chemotherapy. Anticancer Drugs 25:123-125
30. Brown A, Ma Y, Danenberg K, Schuckman AK, Pinski JK, Pagliaro LC, Quinn DI, Dorff TB (2014) Epidermal growth factor receptor-targeted therapy in squamous cell carcinoma of the penis: a report of 3 cases. Urology 83:159-165
31. Chaux A, Munari E, Katz B, Sharma R, Lecksell K, Cubilla AL, Burnett AL, Netto GJ (2013) The epidermal growth factor receptor is frequently overexpressed in penile squamous cell carcinomas: a tissue microarray and digital image analysis study of 112 cases. Hum Pathol 44:2690-2695
32. Carthon BC, Ng CS, Pettaway CA, Pagliaro LC (2014) Epidermal growth factor receptor-targeted therapy in locally advanced or metastatic squamous cell carcinoma of the penis. BJU Int 113:871-877
33. Gou HF, Li X, Qiu M, Cheng K, Li LH, Dong H, Chen Y, Tang Y, Gao F, Zhao F, Men HT, Ge J, Su JM, Xu F, Bi F, Gao JJ, Liu JY (2013) Epidermal growth factor receptor (EGFR)-RAS signaling pathway in penile squamous cell carcinoma. PLoS One 8:e62175