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A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 9 → 15 locations Start date pushed from Aug 18, 2026 to Sep 15, 2026 · Eligibility criteria expanded, about 17 words Show 2 more changesShow less
    • Start date pushed from Aug 18, 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 17 words
  2. Recruitment opened Trial sites expanded: 3 → 9 locations · Start date changed from estimate of Aug 15, 2026 to Aug 18, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 3 → 9 locations
    • Start date changed from estimate of Aug 15, 2026 to Aug 18, 2026
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma, and to evaluate the tolerability in pediatric patients. The objective of this study is to explore the tolerability, safety, efficacy, and pharmacokinetics of ONO-4538HSC in patients with pediatric malignant solid tumors. The other objective is to exploratively investigate the efficacy and safety of ONO-4538HSC in patients with epithelioid sarcoma.
Trial Details
NCT Number NCT07734116
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov