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

NCT07734116 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ONO-4538HSC-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• Adverse events meeting protocol-defined criteria for a DLT

  Cohort of Patients with Pediatric Malignant Solid Tumor

  28 days

• Serious adverse events

  Cohort of Patients with Pediatric Malignant Solid Tumor

  UP to 100 days after the last dose

• Adverse events

  Cohort of Patients with Pediatric Malignant Solid Tumor

  UP to 100 days after the last dose

• Response rate (central assessment)

  Cohort of Epithelioid Sarcoma

  Through study completion, an average of 6 months

Secondary Outcomes (11)

• Serum concentration of nivolumab

  Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

• Response rate (investigator assessment)

  Through study completion, an average of 6 months

• Progression-free survival (central assessment and investigator assessment)

  Through study completion, an average of 6 months

• Disease control rate (central assessment and investigator assessment)

  Through study completion, an average of 6 months

• Duration of response (central assessment and investigator assessment)

  Through study completion, an average of 6 months

Other Outcomes (13)

• Response rate (central assessmen and assessment by site investigator [hereinafter,investigator assessment])

  Through study completion, an average of 6 months

• Overall survival

  Through study completion, an average of 6 months

• Progression-free survival (central assessment and investigator assessment)

  Through study completion, an average of 6 months

Study Arms (1)

ONO-4538HSC

EXPERIMENTAL

Drug: ONO-4538HSC

Interventions

ONO-4538HSC DRUG

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

ONO-4538HSC

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Cohort of pediatric malignant solid tumor Tolerability evaluation part\]
• 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
• \[Common\]

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Project Leader

  Ono Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): February 29, 2032
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)