Clinical trial Recruiting at 13 sites Phase 2 Interventional Ages 1 Year and up

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.

More Rhabdoid Tumor trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages1 Year and up
SexAll
Enrollment23 (estimated)
SponsorOno Pharmaceutical Co., Ltd.
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations14 sites (Nagoya, Aichi-ken and 13 other locations)
StatusRecruiting
StartedNovember 25, 2024
Main results expectedJanuary 31, 2029
Study endsMarch 31, 2030
Registry record updatedAugust 4, 2026
Trial IDNCT06622941 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.