Advanced Solid Tumor Clinical Trial
Official title:
Phase 1 Study of Intratumoral Administration of VAX014 in Subjects With Advanced Solid
The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.
This study will evaluate the safety and tolerability of VAX014 using a 3+3 dose escalation design to determine a maximum tolerated dose (MTD) followed by a dose expansion at the Recommended Phase 2 Dose (RP2D). The DLT assessment period will be the initial 21-days of injections. Subjects will receive weekly injections for the initial 8 weeks. Up to six dose levels will be evaluated (i.e., [starting dose], [starting dose] x 3, [starting dose] x 10, [starting dose] x 30, [starting dose] x 100, [starting dose] x 300). Subjects may continue on treatment following discussion between the Principal Investigator and Sponsor/Medical Monitor. The Expansion Phase will consist of up to 20 subjects. Subjects will receive intratumoral injections at the RP2D declared at the end of the Dose Escalation Phase of the study. The SRC will define the RP2D for use in the Expansion Phase of the study and may redefine the RP2D during the Expansion Phase based on accumulating safety data. ;
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