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A Study of A166 in Patients With Advanced Solid Malignant Tumors

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Primary completion date changed from estimate of Jun 30, 2026 to Apr 9, 2026 · Enrollment target: estimated 120 to confirmed 129 · Start date: Aug 9, 2018 to Aug 1, 2018 · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2026 to Apr 9, 2026
    • Enrollment target: estimated 120 to confirmed 129
    • Start date: Aug 9, 2018 to Aug 1, 2018
    • Eligibility criteria expanded, about 9 words
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary completion date: Jun 30, 2025 to Jun 30, 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 31, 2025 to Dec 31, 2026 · Site details revisedv4 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 31, 2025 to Dec 31, 2026
    • Site details revised
  4. Notable Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Primary completion date: Jun 30, 2023 to Jun 30, 2025 · Completion date: Dec 31, 2023 to Dec 31, 2025v3 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2023 to Jun 30, 2025
    • Completion date: Dec 31, 2023 to Dec 31, 2025
  5. Minor Secondary endpoints: details revised at 1 of 3 entriesv2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
Trial Details
NCT Number NCT05311397
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Breast Cancer
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov