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Recruiting Phase 2

Study to ONO-4538 in Patients With Rhabdoid Tumor

NCT06622941 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2024-11-25
Last updated
2026-08-04

Condition(s) studied

Rhabdoid Tumor

Investigational drug(s) / intervention(s)

ONO-4538 →

ONO-4538: every 2 weeks

Study summary

Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors

Eligibility

Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate (ORR) — up to 4.5 years

Trial sites (14)

FacilityCityRegionStatus
Nagoya University Hospital Nagoya Aichi-ken Recruiting
Hokkaido University Hospital Sapporo Hokkaido Recruiting
Hyogo Prefectural Kobe Children's Hospital Kobe Hyōgo Recruiting
Osaka City General Hospital Osaka Osaka Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
Chiba University Hospital Chiba Japan Recruiting
Kyushu University Hospital Fukuoka Japan Not Yet Recruiting
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06622941 on ClinicalTrials.gov ↗ ← All trials in Japan