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A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 15, 2026 to Aug 7, 2026
    • Study completion pushed from Aug 15, 2026 to Aug 6, 2027
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site details revised at 9 of 9 sites
  2. Primary completion pushed from Mar 15, 2026 to Jun 15, 2026v13
  3. Study arms: 3 to 4v12
  4. Site contacts updated at 1 of 9 sites
    • Eligibility criteria shortened, about 3 words
    v11
  5. Eligibility criteria revised
    • Site details revised at 1 of 9 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria expanded, about 59 words
    • Site contacts updated at 8 of 9 sites
    v9
  2. Enrollment target: 80 to 158v8 Show 8 more changesShow less
    • Primary completion date: May 31, 2023 to Mar 15, 2026
    • Primary endpoints: 4 to 5
    • Study sites: 8 to 9
    • Study completion date: Jun 30, 2023 to Aug 15, 2026
    • Eligibility criteria expanded, about 261 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 60 words
    • Study arms: 2 to 3
  3. Study sites: 6 to 8
    • Eligibility criteria expanded, about 6 words
    v7
  4. Site details revised at 1 of 6 sitesv6
  5. Site details revised at 1 of 6 sitesv5
  6. Site details revised at 1 of 6 sitesv4
  7. Site details revised at 1 of 6 sitesv3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 12, 2021 to Jul 16, 2021
    • Site details revised at 6 of 6 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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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and 2 more diseases
This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours 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 NCT04969835
Lead Sponsor Avacta Life Sciences Ltd
Conditions
(from sponsor)		 Salivary Gland Tumor, Urothelial Carcinoma, Ovarian Carcinoma, Breast Cancer, Soft Tissue Sarcoma
Related terms Breast Neoplasms, Carcinoma, Transitional Cell, Ovarian Neoplasms, Salivary Gland Neoplasms, Sarcoma
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov