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Phase I dose escalation pharmacokinetic assessment of intravenous humanized anti-MUC1 antibody AS1402 in patients with advanced breast cancer
Breast Cancer Research, 10/13/09

Pegram MD et al. – Repeated iv administration of AS1402 was well tolerated, with a maximum tolerated dose (MTD) exceeding 16 mg/kg, the highest dose administered in this study. The half-life and exposure of AS1402 were such that weekly dosing could achieve plasma concentrations corresponding to the maximal ADCC activity observed in vitro. A phase II study is ongoing to evaluate the clinical activity of AS1402 in patients with advanced breast cancer.

Methods

Patients received AS1402 over 1-3 hour intravenous (iv) infusion at doses between 1 and 16 mg/kg, with repeated dosing every 1-3 weeks (based upon patient-individualized PK assessment) until disease progression
Serum AS1402 levels measured at multiple time-points following iv administration
Human anti-human antibody (HAHA) responses were measured to determine the immunogenicity

Results

26 patients treated
AS1402 generally well tolerated
Two grade 3/4 drug-related adverse events reported, both at 3 mg/kg dose
Neither observed in expanded or subsequent dosing cohorts
No anti-human antibodies detected
Plasma concentrations of AS1402 appeared proportional to dose within the 1 to 16 mg/kg dose range assessed, with a mean terminal half-life of 115.4

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