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AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

Study acronym: FOCUS-01
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Trial sites expanded: 3 → 7 locations
    • Eligibility criteria expanded, about 66 words
  2. Enrollment increased: 144 → 174 participants
    • Eligibility criteria expanded, about 4 words
    v4
  3. Study sites: 2 to 3
    • Start date changed from estimate of Mar 2026 to Mar 31, 2026
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Avacta Life Sciences Ltd
2 trials monitored
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See 296 trials at risk
Lung Cancer
4,790 trials monitored
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Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
and 4 more diseases
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.
Trial Details
NCT Number NCT07454642
Lead Sponsor Avacta Life Sciences Ltd
Conditions
(from sponsor)		 Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Small Cell Carcinoma of Lung, Colorectal Cancer +1 more
Related terms Colorectal Neoplasms, Small Cell Lung Carcinoma
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov