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

NCT07734116 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Pediatric Malignant Solid Tumor and Epithelioid Sarcoma

Interventions

DRUG

ONO-4538HSC

ONO-4538HSC will be administered subcutaneously once every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2029-11-30
Completion
2032-02-29

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734116 on ClinicalTrials.gov