Clinical Trial

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

Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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 2026-08-15
Primary Completion 2029-11-30 (estimated)
Study Completion 2032-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-29