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NCT Number: NCT07734116

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

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.

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Key information

Conditions

Pediatric Malignant Solid Tumor and Epithelioid Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chiba University Hospital, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

[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 criteria

  • 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

Treatment and study plan

ONO-4538HSC

Drug

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

Primary outcomes

  1. Adverse events meeting protocol-defined criteria for a DLT

    Time frame: 28 days

    Cohort of Patients with Pediatric Malignant Solid Tumor

  2. Serious adverse events

    Time frame: UP to 100 days after the last dose

    Cohort of Patients with Pediatric Malignant Solid Tumor

  3. Adverse events

    Time frame: UP to 100 days after the last dose

    Cohort of Patients with Pediatric Malignant Solid Tumor

  4. Response rate (central assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Epithelioid Sarcoma

Secondary outcomes

  1. Serum concentration of nivolumab

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

    Cohort of Patients with Pediatric Malignant Solid Tumor

  2. Response rate (investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  3. Progression-free survival (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  4. Disease control rate (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  5. Duration of response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  6. Time to response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  7. Best overall response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  8. Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  9. Changes in tumor markers over time

    Time frame: Through study completion, an average of 6 months

    Cohort of epithelioid sarcoma

  10. Adverse events

    Time frame: UP to 100 days after the last dose

    Cohort of epithelioid sarcoma

  11. Serum concentration of nivolumab

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

    Cohort of epithelioid sarcoma

Other outcomes

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

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  2. Overall survival

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  3. Progression-free survival (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  4. Disease control rate (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  5. Duration of response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  6. Time to response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  7. Best overall response (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  8. Percent change from baseline in the sum of tumor diameters of target lesions (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  9. Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment)

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  10. Changes in tumor markers over time

    Time frame: Through study completion, an average of 6 months

    Cohort of Patients with Pediatric Malignant Solid Tumor

  11. Analysis of efficacy, etc. with PD-L1 expression (measured at the central laboratory) and collected parameters

    Time frame: Screening

    Common to both cohorts

  12. Anti-nivolumab antibody

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

    Common to both cohorts

  13. Anti-rHuPH20 antibodies

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

    Common to both cohorts

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Jul 29, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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