A phase I/II trial of multiple dose VB-111 and weekly paclitaxel in recurrent platinum-resistant Müllerian cancer.

5542 Background: VB-111 is a gene therapy agent consisting of a non-replicating adenovirus vector (Ad-5) with a modified murine pre-proendothelin promoter leading to apoptosis of tumor vasculature by expressing a fas-chimera transgene in angiogenic endothelial cells. One hundred and sixty five patients have been treated so far with VB-111 across different cancer indications including Recurrent GBM, advanced well differentiated thyroid carcinoma with preliminary evidence of anti-tumor activity with no significant safety issues. Safety of VB-111 in combination with paclitaxel was evaluated for patients with recurrent Mullerian cancers in a phase I/II dose-escalation study. Methods: VB-111 was administered as a single intravenous infusion at escalating doses from 3x1012 (DL1&2) to 1x1013 viral particles (VPs) (DL3), followed by repeat doses every 2 months. Paclitaxel was given at 40 mg/m2 (DL1), and 80mg/m2 weekly (DL2-3), with a planned dose expansion at DL3. Assessments included safety, pharmacokinetics, p...