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

RecruitingPhase 1, Phase 2Ages 12 Years - anyAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \[Cohort of pediatric malignant solid tumor Tolerability evaluation part\] 1. Patients aged โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • ONO-4538HSC
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Where

15 sites
Chiba University Hospital
Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Kyushu University Hospital
Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Japan
Kanazawa University Hospital
Kanazawa, Japan
Yokohama City University Hospital
Yokohama, Japan
Kyoto University Hospital
Kyoto, Japan

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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