AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
brief summary
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
detailed description
Phase 1a (Dose Escalation): The dose-escalation portion is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6103, administered as monotherapy in two schedules: Day 1 of a 21-day cycle (Q3W schedule) and Day 1 of a 14-day cycle (Q2W schedule).
Phase 1b (Dose Expansion): The dose-expansion arm is based on review of data in the dose escalation phase, with AVA6103 administered at the RP2D.
official title
A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors