Study to ONO-4538 in Patients With Rhabdoid Tumor
August 2, 2026 updated by: Ono Pharmaceutical Co., Ltd.
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Study Overview
Study Type
Interventional
Enrollment (Estimated)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: North America Clinical Trial Support Desk
- Phone Number: +18665877745(Toll-Free)
- Email: clinical_trial@ono-pharma.com
Study Contact Backup
- Name: International Clinical Trial Support Desk
- Phone Number: +17162141777(Standard)
- Email: clinical_trial@ono-pharma.com
Study Locations
-
-
-
Chiba, Japan
- Recruiting
- Chiba University Hospital
-
Fukuoka, Japan
- Not yet recruiting
- Kyushu University Hospital
-
Fukushima, Japan
- Recruiting
- Fukushima Medical University Hospital
-
Hiroshima, Japan
- Recruiting
- Hiroshima University Hospital
-
Kanazawa, Japan
- Recruiting
- Kanazawa University Hospital
-
Kyoto, Japan
- Recruiting
- University Hospital, Kyoto Prefectural University of Medicine
-
Miyagi, Japan
- Recruiting
- Tohoku University Hospital
-
Niigata, Japan
- Recruiting
- Niigata University Medical & Dental Hospital
-
Tokyo, Japan
- Recruiting
- National Center for Child Health and Development
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan
- Recruiting
- Nagoya University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, Japan
- Recruiting
- Hyogo Prefectural Kobe Children's Hospital
-
-
Osaka
-
Osaka, Osaka, Japan
- Recruiting
- Osaka City General Hospital
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan
- Recruiting
- National Cancer Center Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Gender: Not specified
- Age (at the time of consent): 1 year or older
- Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors
- Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection
Exclusion Criteria:
- Patients with a history of active concurrent malignancy or complications
- Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period
- Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ONO-4538
|
every 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rate (ORR)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rate (ORR) (site investigator assesment)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Overall survival (OS)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Progression free survival (PFS)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Disease control rate (DCR)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Time to response (TTR)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Best overall response (BOR)
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Percent change from baseline in the sum of diameters of target lesions
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Best reduction percent change from baseline in the sum of diameters of target lesions
Time Frame: up to 4.5 years
|
up to 4.5 years
|
|
Incidence of Adverse Events [Safety]
Time Frame: Up to 30 days after the last dose
|
Up to 30 days after the last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Project Leader, Ono Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2024
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
March 31, 2030
Study Registration Dates
First Submitted
September 30, 2024
First Submitted That Met QC Criteria
September 30, 2024
First Posted (Actual)
October 2, 2024
Study Record Updates
Last Update Posted (Actual)
August 4, 2026
Last Update Submitted That Met QC Criteria
August 2, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONO-4538-126
- jRCT2051240150 (Registry Identifier: Japan Registry of Clinical Trials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.