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

NCT ID: NCT06622226

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

Non Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evaluation of Tolerability

Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.

Group Type: EXPERIMENTAL

ONO-7018

Intervention Type: DRUG

ONO-7018 tablet(s) are administered orally.

Interventions

ONO-7018

ONO-7018 tablet(s) are administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient with histologically/cytologically confirmed diagnosis of any of the subtypes of B-cell NHL or T-cell NHL defined below as documented by medical records and with histology based on criteria established by the World Health Organization (Swerdlow 2017)

2. Relapsed or refractory patient who is refractory or intolerant to standard therapy or for whom, in the opinion of the investigator, there is no appropriate treatment for the primary disease.

3. Patient who has measurable disease

4. Eastern Cooperative Oncology Group Performance Status 0 to 2

5. Life expectancy of at least 3 months

3. Prior treatment with a MALT1 inhibitor

4. Patient is unable to swallow tablets

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa-shi, Gunma, Japan

Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

National Hospital Organization Osaka National Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

jRCT2021240028

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-7018-03

Identifier Type: -

Identifier Source: org_study_id