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.
Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
Patients with radically/curatively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available.
Patients with ECOG PS of 0 to 1
Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
Patients with current or previous severe hypersensitivity reactions to antibody products
Patients with primary central nervous system tumor
Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.
Patients with multiple cancers
Single group
ONO-4538HSC
DrugONO-4538HSC will be administered subcutaneously once every 4 weeks.
Adverse events meeting protocol-defined criteria for a DLT
Cohort of Patients with Pediatric Malignant Solid Tumor
Serious adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Response rate (central assessment)
Cohort of Epithelioid Sarcoma
Serum concentration of nivolumab
Cohort of Patients with Pediatric Malignant Solid Tumor
Response rate (investigator assessment)
Cohort of epithelioid sarcoma
Progression-free survival (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Disease control rate (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Response rate (central assessmen and assessment by site investigator [hereinafter,investigator assessment])
Cohort of Patients with Pediatric Malignant Solid Tumor
Overall survival
Cohort of Patients with Pediatric Malignant Solid Tumor
Progression-free survival (central assessment and investigator assessment)
Cohort of Patients with Pediatric Malignant Solid Tumor
Disease control rate (central assessment and investigator assessment)
Cohort of Patients with Pediatric Malignant Solid Tumor
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