Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck

Lars Bastholt; Lena Specht; Kenneth Jensen; Eva Brun; Annika Loft; Jørgen Petersen; Helle Kastberg; Jesper G Eriksen

doi:10.1016/j.radonc.2007.06.007

Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck

Lars Bastholt, Lena Specht, Kenneth Jensen, Eva Brun, Annika Loft, Jørgen Petersen, Helle Kastberg, Jesper G Eriksen

39 Citations (Scopus)

Abstract

PURPOSE: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. PATIENTS AND METHODS: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. RESULTS: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. CONCLUSIONS: HuMax-EGFr can be safely administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging.

Original language	English
Journal	Radiotherapy & Oncology
Volume	85
Issue number	1
Pages (from-to)	24-8
Number of pages	5
ISSN	0167-8140
DOIs	https://doi.org/10.1016/j.radonc.2007.06.007
Publication status	Published - 2007

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10.1016/j.radonc.2007.06.007

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Bastholt, L., Specht, L., Jensen, K., Brun, E., Loft, A., Petersen, J., Kastberg, H., & Eriksen, J. G. (2007). Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiotherapy & Oncology, 85(1), 24-8. https://doi.org/10.1016/j.radonc.2007.06.007

Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. / Bastholt, Lars; Specht, Lena; Jensen, Kenneth et al.

In: Radiotherapy & Oncology, Vol. 85, No. 1, 2007, p. 24-8.

Research output: Contribution to journal › Journal article › Research › peer-review

Bastholt, L, Specht, L, Jensen, K, Brun, E, Loft, A, Petersen, J, Kastberg, H & Eriksen, JG 2007, 'Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck', Radiotherapy & Oncology, vol. 85, no. 1, pp. 24-8. https://doi.org/10.1016/j.radonc.2007.06.007

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title = "Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck",

abstract = "PURPOSE: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. PATIENTS AND METHODS: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. RESULTS: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. CONCLUSIONS: HuMax-EGFr can be safely administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging.",

author = "Lars Bastholt and Lena Specht and Kenneth Jensen and Eva Brun and Annika Loft and J{\o}rgen Petersen and Helle Kastberg and Eriksen, {Jesper G}",

note = "Keywords: Aged; Antibodies, Monoclonal; Carcinoma, Squamous Cell; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Receptor, Epidermal Growth Factor",

year = "2007",

doi = "10.1016/j.radonc.2007.06.007",

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T1 - Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck

AU - Bastholt, Lars

AU - Specht, Lena

AU - Jensen, Kenneth

AU - Brun, Eva

AU - Loft, Annika

AU - Petersen, Jørgen

AU - Kastberg, Helle

AU - Eriksen, Jesper G

N1 - Keywords: Aged; Antibodies, Monoclonal; Carcinoma, Squamous Cell; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Receptor, Epidermal Growth Factor

PY - 2007

Y1 - 2007

N2 - PURPOSE: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. PATIENTS AND METHODS: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. RESULTS: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. CONCLUSIONS: HuMax-EGFr can be safely administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging.

AB - PURPOSE: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. PATIENTS AND METHODS: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. RESULTS: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. CONCLUSIONS: HuMax-EGFr can be safely administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging.

U2 - 10.1016/j.radonc.2007.06.007

DO - 10.1016/j.radonc.2007.06.007

M3 - Journal article

C2 - 17602769

SN - 0167-8140

VL - 85

SP - 24

EP - 28

JO - Radiotherapy & Oncology

JF - Radiotherapy & Oncology

IS - 1

ER -

Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck

Abstract

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