Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
Conditions
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.
Interventions
DRUGONO-4538HSC
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events meeting protocol-defined criteria for a DLT | 28 days | Cohort of Patients with Pediatric Malignant Solid Tumor |
| Serious adverse events | UP to 100 days after the last dose | Cohort of Patients with Pediatric Malignant Solid Tumor |
| Adverse events | UP to 100 days after the last dose | Cohort of Patients with Pediatric Malignant Solid Tumor |
| Response rate (central assessment) | Through study completion, an average of 6 months | Cohort of Epithelioid Sarcoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Cohort of Patients with Pediatric Malignant Solid Tumor |
| Response rate (investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Progression-free survival (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Disease control rate (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Duration of response (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Time to response (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Best overall response (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment) | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Changes in tumor markers over time | Through study completion, an average of 6 months | Cohort of epithelioid sarcoma |
| Adverse events | UP to 100 days after the last dose | Cohort of epithelioid sarcoma |
Countries
Japan
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed