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Sub-category:
Antibodies
Category:
Developmental Therapeutics - Immunotherapy
Meeting:
2003 ASCO Annual Meeting
Abstract No:
722
Citation:
Proc Am Soc Clin Oncol 22: 2003 (abstr 722)
Author(s):
M. A. Carabasi, N. L. Bartlett, A. Younes, D. M. Miller, S. D. Schliebner, C. B. Siegall, A. P. Sing; USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, CA; Siteman Cancer Center/Washington University, St. Louis, St. Louis, MO; MD Anderson Cancer Center, Houston, TX; Seattle Genetics, Inc., Bothell, WA
Abstract:
SGN-30, a chimeric anti-CD30 mAb, has demonstrated antitumor activity in preclinical models of Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL) in vitro and in vivo. CD30 is expressed on relatively few normal tissues, suggesting that SGN-30 may have a wide therapeutic window as a treatment for hematologic malignancies. A phase I dose-escalation study was conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of a single IV infusion of SGN-30 in patients (pts) with relapsed or refractory CD30+ hematologic malignancies. Thirteen pts received a single dose of SGN-30 at doses ranging from 1.0 to 15.0 mg/kg. Serum samples were collected for PK analysis pre-dose, and at 1, 24, and 48 hrs, and 8, 15, 22, and 29 days post-dose. SGN-30 concentrations were determined by an anti-idiotype capture ELISA. Non-compartmental PK analysis revealed that the area under the curve (AUC) increased proportional to increasing SGN-30 dose. The volume of distribution for SGN-30 was estimated to be 100 ml/kg, consistent with distribution to blood volume and similar to other monoclonal antibodies. The half-life of SGN-30 was approximately 25 plus/minus 15 days. No apparent gender or disease differences in PK were observed. Human anti-chimeric antibody (HACA) response was observed in only one patient at a low titer of 1:100. A single IV dose of SGN-30 was well tolerated in the majority of pts. One patient experienced an infusion reaction (grade II allergy) within the first 30 minutes of administration that responded immediately to medical intervention. Based upon the safety, tolerability, and early evidence of antitumor activity in the phase I trial, the development of SGN-30 has been accelerated into a phase I/II trial evaluating the weekly administration of SGN-30 in pts with CD30+ hematologic malignancies.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by M. A. Carabasi:
Presentations by M. A. Carabasi:
Educational Book Manuscripts by M. A. Carabasi:
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