ONO-4538HSC for Children With Solid Tumors and People With Epithelioid Sarcoma
Tests ONO-4538HSC in children with solid cancers and people with epithelioid sarcoma.
Plain-language title generated from the registry record
Registry title: A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
Key facts
- Where
- Chiba, Chuo Ku, Fukuoka, Hiroshima, Kanazawa, Kashiwa, Kyoto, Okayama, Osaka, Sakai, Sapporo, Sendai, Sunto-gun, Tsu, and Yokohama, JapanSee the 15 sites
- Phase
- Phase 1/2
Where in Japan
- Chiba University HospitalChiba, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanTaking people
- Kyushu University HospitalFukuoka, JapanTaking people
- Hiroshima University HospitalHiroshima, JapanNot yet recruiting
- Kanazawa University HospitalKanazawa, JapanNot yet recruiting
- National Cancer Center Hospital EastKashiwa, JapanNot yet recruiting
- Kyoto University HospitalKyoto, JapanTaking people
- Okayama University HospitalOkayama, JapanNot yet recruiting
- Osaka International Cancer InstituteOsaka, JapanTaking people
- Kindai University HospitalSakai, JapanNot yet recruiting
- Hokkaido University HospitalSapporo, JapanTaking people
- Tohoku University HospitalSendai, JapanNot yet recruiting
- Shizuoka Cancer CenterSunto-gun, JapanNot yet recruiting
- Mie University HospitalTsu, JapanNot yet recruiting
- Yokohama City University HospitalYokohama, JapanNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT07734116
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: [Cohort of pediatric malignant solid tumor Tolerability evaluation part]; 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; [Cohort of pediatric malignant solid tumor Expansion part]; Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF); Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert; Patients who have at least 1 measurable lesion per RECIST guideline; Patients with ECOG PS of 0 to 2; [Cohort of Epithelioid Sarcoma]; Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to < 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor; Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma; Patients who have at least 1 measurable lesion per RECIST guideline; Patients with ECOG PS of 0 to 2; [Common]; Life expectancy ≥ 3 months at the time of enrollment.
Exclusion: Patients with current or previous severe hypersensitivity reactions to antibody products; Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells; Patients with multiple cancers; 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.