ONO-4538HSC in children with solid tumors or epithelioid sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase 1/2 study evaluating ONO-4538HSC in pediatric patients with malignant solid tumors and a separate group with epithelioid sarcoma. The trial aims to characterize safety, tolerability, pharmacokinetics, and preliminary efficacy, with escalation cohorts for tolerability and expansion cohorts for efficacy signals. Eligible participants include adolescents aged 12 to under 18 with unresectable or advanced disease (and measurable lesions for epithelioid sarcoma) and acceptable performance status. The study is conducted at major Japanese cancer centers and is sponsored by Ono Pharmaceutical Co., with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

1. Patients aged ≥ 12 to \< 18 years at the time of signing the informed consent form (ICF)
2. 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.
3. Patients with ECOG PS of 0 to 1

   \[Cohort of pediatric malignant solid tumor Expansion part\]
4. Patients aged ≥ 12 to \< 18 years at the time of signing the informed consent form (ICF)
5. Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert
6. Patients who have at least 1 measurable lesion per RECIST guideline
7. Patients with ECOG PS of 0 to 2

   \[Cohort of Epithelioid Sarcoma\]
8. 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.
9. Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma
10. Patients who have at least 1 measurable lesion per RECIST guideline
11. Patients with ECOG PS of 0 to 2

    \[Common\]
12. Life expectancy ≥ 3 months at the time of enrollment

Exclusion Criteria:

1. Patients with current or previous severe hypersensitivity reactions to antibody products
2. Patients with primary central nervous system tumor
3. Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.
4. Patients with multiple cancers
5. 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

Where it's running

• Chiba University Hospital
  Chiba, Chiba, Japan Recruiting
• Kyushu University Hospital
  Fukuoka, Fukuoka, Japan Recruiting
• Hokkaido University Hospital
  Sapporo, Hokkaido, Japan Recruiting
• Kyoto University Hospital
  Kyoto, Kyoto, Japan Recruiting
• Osaka International Cancer Institute
  Osaka, Osaka, Japan Recruiting
• National Cancer Center Hospital
  Chuo-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745(Toll-Free)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.