Abstract
9028 Background: TGFβ is a pleiotropic cytokine that normally helps maintain tissue homeostasis. However, in advanced cancers, TGFβ is often overexpressed and associated with higher pathologic grade, increased frequency of metastases, and poorer survival. In such cancers, TGFβ signaling is often altered, and TGFβ becomes a tumor promoter by stimulating tumor cell proliferation/migration/invasion and angiogenesis, by activating stromal cells, and by suppressing anti-tumor immunity. GC1008 is a human IgG4 MAb capable of neutralizing TGFβ isoforms 1, 2, & 3. We report the results of an ongoing, first in cancer, multi-center trial examining the safety and effectiveness of GC1008. Methods: Cohorts of patients (Pts) with advanced MM or RCC who had failed ≥ 1 prior therapy (Tx) were treated with GC1008 at 1 of 6 dose levels (0.1, 0.3, 1, 3, 10 or 15mg/kg) in a 3+3 design. If no DLTs occurred within 28 days of the first dose, 3 additional doses were administered 2wks apart. Tumor response was determined by RECIST...
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