Clinical Trial

AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

Study acronym: FOCUS-01
Recruiting Phase 1
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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.
Protocol Amendment History 1 change
notable Enrollment increased: 144 -> 174 participants 2026-06-03
Trial Details
NCT Number NCT07454642
Lead Sponsor Avacta Life Sciences Ltd
Conditions Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Small Cell Carcinoma of Lung, Colorectal Cancer +1 more
Enrollment 174 participants
Start Date 2026-03-31
Primary Completion 2029-01 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-02