A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epi… (NCT07734116) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
Japan50 participantsStarted 2026-08-15
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events meeting protocol-defined criteria for a DLT
Timeframe: 28 days
2
Serious adverse events
Timeframe: UP to 100 days after the last dose
3
Adverse events
Timeframe: UP to 100 days after the last dose
4
Response rate (central assessment)
Timeframe: Through study completion, an average of 6 months
. 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.
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