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.
OBJECTIVE
To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN.


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.
Bastholt
Lars
L
Odense University Hospital, Denmark. lars.bastholt@ouh.regionsyddanmark.dk
Specht
Lena
L
Jensen
Kenneth
K
Brun
Eva
E
Loft
Annika
A
Petersen
Jørgen
J
Kastberg
Helle
H
Eriksen
Jesper G
JG
D000368:Aged; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged
D000911:Antibodies, Monoclonal; D066246:ErbB Receptors