RecruitingPhase 1Phase 2NCT07734116

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

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.


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

50 participants

Start Date

Aug 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ONO-4538HSC for people with pediatric malignant solid tumor and epithelioid sarcoma. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONO-4538HSC

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


Locations(9)

Chiba University Hospital

Chiba, Chiba, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

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NCT07734116