Pediatric Malignant Solid Tumor and Epithelioid SarcomaPhase 1/2NCT07734116
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
A Phase 1/2 study testing ONO-4538HSC in people with Pediatric Malignant Solid Tumor and Epithelioid Sarcoma, run by Ono Pharmaceutical Co., Ltd. at 15 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
- What is being tested?
- ONO-4538HSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesJapan
- Study dates
- 15 Sep 2026to 29 Feb 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- [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)
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- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
15 sites in 1 country
Japan15 sites, 15 recruiting
- Recruiting
Chiba University Hospital
Chiba, Chiba
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka
- Not yet recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima
- Not yet recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken
- Not yet recruiting
National Cancer Center Hospital East
Kashiwa, Chiba
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto
- Not yet recruiting
Okayama University Hospital
Okayama, Okayama-ken
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka
- Not yet recruiting
Kindai University Hospital
Sakai, Osaka
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido
- Not yet recruiting
Tohoku University Hospital
Sendai, Miyagi
- Not yet recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka
- Not yet recruiting
Mie University Hospital
Tsu, Mie-ken
- Not yet recruiting
Yokohama City University Hospital
Yokohama, Kanagawa
About this study
Official 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.
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.
- Being tested
- ONO-4538HSC
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538HSCDrug
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538HSC | Experimental | Not described Receives: Drug: ONO-4538HSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events meeting protocol-defined criteria for a DLT
Cohort of Patients with Pediatric Malignant Solid Tumor
Measured: 28 days
Serious adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Measured: UP to 100 days after the last dose
Adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Measured: UP to 100 days after the last dose
Response rate (central assessment)
Cohort of Epithelioid Sarcoma
Measured: Through study completion, an average of 6 months
Secondary outcomes (11)
Serum concentration of nivolumab
Cohort of Patients with Pediatric Malignant Solid Tumor
Measured: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Response rate (investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Progression-free survival (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Disease control rate (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Duration of response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Time to response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Best overall response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Changes in tumor markers over time
Cohort of epithelioid sarcoma
Measured: Through study completion, an average of 6 months
Adverse events
Cohort of epithelioid sarcoma
Measured: UP to 100 days after the last dose
Serum concentration of nivolumab
Cohort of epithelioid sarcoma
Measured: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Sep 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion29 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Malignant Solid Tumor and Epithelioid SarcomaStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734116
- Sponsor's protocol ID
- ONO-4538HSC-04
- Other IDs
- jRCT2031260289
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07734116
- Acronym / sponsor ID
- ONO-4538HSC-04
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 29 Feb 2032 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4538HSC | Experimental | Drug: ONO-4538HSC |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- [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]
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538HSCONO-4538HSC will be administered subcutaneously once every 4 weeks. | Drug | ONO-4538HSC |
Primary outcome
Adverse events meeting protocol-defined criteria for a DLT
Time frame: 28 days
Cohort of Patients with Pediatric Malignant Solid Tumor
Serious adverse events
Time frame: UP to 100 days after the last dose
Cohort of Patients with Pediatric Malignant Solid Tumor
Adverse events
Time frame: UP to 100 days after the last dose
Cohort of Patients with Pediatric Malignant Solid Tumor
Response rate (central assessment)
Time frame: Through study completion, an average of 6 months
Cohort of Epithelioid Sarcoma
11 secondary outcomes
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)
Response rate (investigator assessment)
Time frame: Through study completion, an average of 6 months
Progression-free survival (central assessment and investigator assessment)
Time frame: Through study completion, an average of 6 months
Disease control rate (central assessment and investigator assessment)
Time frame: Through study completion, an average of 6 months
Duration of response (central assessment and investigator assessment)
Time frame: Through study completion, an average of 6 months
Time to response (central assessment and investigator assessment)
Time frame: Through study completion, an average of 6 months
Best overall response (central assessment and investigator assessment)
Time frame: Through study completion, an average of 6 months
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
Changes in tumor markers over time
Time frame: Through study completion, an average of 6 months
Adverse events
Time frame: UP to 100 days after the last dose
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ONO-4538HSC in people with Pediatric Malignant Solid Tumor and Epithelioid Sarcoma, run by Ono Pharmaceutical Co., Ltd. at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events meeting protocol-defined criteria for a DLT (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.