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A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints revised (11)
    • Site details revised at 1 of 4 sites
    v4
  2. Start date changed from estimate of Feb 2025 to Mar 11, 2025v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Collaborators expanded, about 11 words
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.
Trial Details
NCT Number NCT06687941
Lead Sponsor Aptamer Sciences, Inc.
Collaborators: CHA University, National Cancer Center, Korea, Samsung Medical Center, Severance Hospital
Conditions
(from sponsor)		 Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms, Neoplasm Metastasis, Neoplasms, Simpson-Golabi-Behmel syndrome
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov