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A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Apr 2026 → May 2027
See other at-risk trials from Georgetown University

Record History

  1. Primary completion pushed from Apr 2026 to May 2027 Completion pushed from Dec 2026 to Dec 2027v8 Show 1 more changeShow less
    • Completion pushed from Dec 2026 to Dec 2027
  2. Study sites: 3 to 4v7
  3. Study sites: 2 to 3v6
  4. Study sites: 1 to 2v5
  5. Primary completion date: Jul 2025 to Apr 2026 Completion date: Jul 2025 to Dec 2026 · Start date changed from estimate of May 2024 to Apr 25, 2024v4 Show 2 more changesShow less
    • Completion date: Jul 2025 to Dec 2026
    • Start date changed from estimate of May 2024 to Apr 25, 2024
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2024 to May 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Jul 2024 to May 2024
    • Site details revised
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: • What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma? Participants will: * receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity * have regular blood tests, scans, and examinations to monitor their health. * have blood and a biopsy of their tumor for research purposes.
Trial Details
NCT Number NCT06248515
Lead Sponsor Georgetown University
Collaborators: Gilead Sciences
Conditions Thymoma, Thymic Carcinoma
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov