A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Last updated: February 16, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Treatment

ONO-7018

Clinical Study ID

NCT06622226
ONO-7018-03
jRCT2021240028
  • Ages > 18
  • All Genders

Study Summary

ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL. This study is Phase1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (biomarkers) and efficacy of ONO-7018 in patients with relapsed or refractory NHL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient with histologically/cytologically confirmed diagnosis of any of the subtypesof B-cell NHL or T-cell NHL defined below as documented by medical records and withhistology based on criteria established by the World Health Organization (Swerdlow

  1. Relapsed or refractory patient who is refractory or intolerant to standard therapyor for whom, in the opinion of the investigator, there is no appropriate treatmentfor the primary disease.

  2. Patient who has measurable disease

  3. Eastern Cooperative Oncology Group Performance Status 0 to 2

  4. Life expectancy of at least 3 months

Exclusion

Exclusion Criteria:

  1. Any serious or uncontrolled medical disorder that may increase the risk associatedwith study participation or study treatment, or interfere with the interpretation ofstudy results

  2. Patient with malignancies other than lymphoid malignancy allowed per inclusioncriteria

  3. Prior treatment with a MALT1 inhibitor

  4. Patient is unable to swallow tablets

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: ONO-7018
Phase: 1
Study Start date:
November 27, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Nagoya City University Hospital

    Nagoya-shi, Aichi
    Japan

    Site Not Available

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa-shi, Gumma
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital

    Hiroshima-shi, Hiroshima
    Japan

    Site Not Available

  • National Hospital Organization Sendai Medical Center

    Sendai-shi, Miyagi
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital

    Osaka,
    Japan

    Site Not Available

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