All patients in the trial have undergone radiographic re-evaluation to assess their response to treatment. Based on this assessment, two patients remain on study drug beyond the original treatment period. A total of four patients received extended therapy in both the original cohort and the expanded cohort of this trial.
The appropriate dose and schedule of RAV12 previously was chosen in a dose-escalation segment of the Phase I/IIa trial that involved 33 patients. This trial revealed that a fractionated dosing regimen provided an improved side effect profile for the antibody. The recently concluded maximum tolerated dose (MTD) Cohort Expansion segment involved 20 additional patients.