Study to ONO-4538 in Patients With Rhabdoid Tumor

Last updated: March 4, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

ONO-4538

Clinical Study ID

NCT06622941
ONO-4538-126
jRCT2051240150
  • Ages > 1
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 chemotherapyfor rhabdoid Tumors

  4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curativeresection

Exclusion

Exclusion Criteria:

  1. Patients with a history of active concurrent malignancy or complications

  2. Patients with spinal lesions expected to require radiation therapy or surgicalintervention during the trial period

  3. Patients with concomitant central nervous system disorders other than AT/RT that areinadequately controlled or may lead to discontinuation of the investigational drug

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: ONO-4538
Phase: 2
Study Start date:
November 25, 2024
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • Nagoya University Hospital

    Nagoya, Aichi
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka,
    Japan

    Active - Recruiting

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