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