Background: The human monoclonal antibody SK-1 recognizes a glycoprotein ex
pressed on the majority of colon cancer tissues. In the current study, we e
valuated the safety, toxicity and preliminary efficacy of escalating dosage
s of SK-1 in patients with advanced colon cancer. Patients and Methods: SK-
1 was administered intravenously at 2, 4 or 10 mg three times to three grou
ps of patients with recurrent colon cancer. The clinical outcome and the in
duction of serum anti-idiotypic antibody (Ab2) were assessed periodically.
Results: The mean rate of serum CEA level increase declined significantly d
uring the eight weeks following the treatment. In four patients, serum tite
r of anti-idiotypic IgG antibodies to SK-1 (Ab2) continued to increase foll
owing the treatment. Conclusion: HuMAb SK-1 was well-tolerated and can be s
afely administered. It was suggested that SK-1 natural antibody not only po
ssessed direct cytostatic activity against colon carcinoma, but may also ha
ve induced carcinoma-related, anti-idiotypic antibody responses.