Treatment of rhabdoid tumors with ONO-4538
Official title: A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Run by Ono Pharmaceutical Co., Ltd. · NCT06622941 · Data updated 2026-11-12
This study is testing a new treatment called ONO-4538 for people with advanced or recurring rhabdoid tumors who haven't had success with regular chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 23 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 14 sites (Nagoya, Aichi-ken and 13 other locations) |
| Status | Recruiting |
| Started | November 25, 2024 |
| Main results expected | January 31, 2029 |
| Study ends | March 31, 2030 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT06622941 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 1 year or older with advanced or recurrent rhabdoid tumors who are refractory or intolerant to previous chemotherapy.
✕Probably not a fit
Patients with active concurrent malignancies or those requiring immediate radiation therapy or surgical intervention for spinal lesions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the efficacy and safety of ONO-4538, a novel treatment, in patients suffering from rhabdoid tumors. It focuses on individuals who have advanced or recurrent forms of this rare cancer and have not responded to standard chemotherapy regimens. The trial aims to assess how well this new intervention works in managing the disease and improving patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with rhabdoid tumors who have limited treatment choices.
How similar studies have gone: While there may be limited data on ONO-4538 specifically, similar approaches targeting rare tumors have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gender: Not specified 2. Age (at the time of consent): 1 year or older 3. Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors 4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection Exclusion Criteria: 1. Patients with a history of active concurrent malignancy or complications 2. Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period 3. Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
Where it's running
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan Recruiting -
Hokkaido University Hospital
Sapporo, Hokkaido, Japan Recruiting -
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, Japan Recruiting -
Osaka City General Hospital
Osaka, Osaka, Japan Recruiting -
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan Recruiting -
Chiba University Hospital
Chiba, Japan Recruiting
Show 8 more locations
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Fukushima Medical University Hospital
Fukushima, Japan Recruiting -
Hiroshima University Hospital
Hiroshima, Japan Recruiting -
Kanazawa University Hospital
Kanazawa, Japan Recruiting -
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan Recruiting -
Tohoku University Hospital
Miyagi, Japan Recruiting -
Niigata University Medical & Dental Hospital
Niigata, Japan Recruiting -
National Center for Child Health and Development
Tokyo, Japan Recruiting -
Kyushu University Hospital
Fukuoka, Japan Not yet recruiting
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.