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

July 28, 2026 updated by: Ono Pharmaceutical Co., Ltd.

A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) in Japan

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan
        • Nagoya City University Hospital
    • Gunma
      • Shibukawa-shi, Gunma, Japan
        • National Hospital Organization Shibukawa Medical Center
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital
    • Miyagi
      • Sendai, Miyagi, Japan
        • National Hospital Organization Sendai Medical Center
    • Osaka
      • Osaka, Osaka, Japan
        • National Hospital Organization Osaka National Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japan
        • The Cancer Institute Hospital of JFCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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
  2. Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
  3. Prior treatment with a MALT1 inhibitor
  4. Patient is unable to swallow tablets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: ONO-7018
ONO-7018 tablet(s) are administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicities
Time Frame: up to 3 weeks after the first dose
Observed toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 to assess the tolerability of ONO-7018.
up to 3 weeks after the first dose
Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Up to 28 days after the last dose
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
Up to 28 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration of ONO-7018
Time Frame: up to 16 weeks after the first dose
Plasma concentration will be assessed to evaluate Pharmacokinetics.
up to 16 weeks after the first dose
Maximum observed concentration (Cmax)
Time Frame: up to 16 weeks after the first dose
To assess the PK profile of ONO-7018
up to 16 weeks after the first dose
Time to Cmax (Tmax)
Time Frame: up to 16 weeks after the first dose
To assess the PK profile of ONO-7018
up to 16 weeks after the first dose
Area under the concentration-time curve to the end of the dosing period (AUCtau)
Time Frame: up to 16 weeks after the first dose
To assess the PK profile of ONO-7018
up to 16 weeks after the first dose
Elimination half-life (T1/2)
Time Frame: up to 16 weeks after the first dose
To assess the PK profile of ONO-7018
up to 16 weeks after the first dose
Predose trough concentration (Ctrough)
Time Frame: up to 16 weeks after the first dose
To assess the PK profile of ONO-7018
up to 16 weeks after the first dose
Overall Response Rate (ORR)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Complete response rate (CRR)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Best overall response (BOR)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Duration of response (DOR)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Time to response (TTR)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Progression-free survival (PFS)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.
through study completion, an average of 1 year
Overall survival (OS)
Time Frame: through study completion, an average of 1 year
Antitumor activity of ONO-7018 as measured by OS will be assessed.
through study completion, an average of 1 year
Percent change of tumor volume
Time Frame: through study completion, an average of 1 year
Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.
through study completion, an average of 1 year
Maximum percent reduction of tumor volume
Time Frame: through study completion, an average of 1 year
Maximum percent reduction of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Actual)

April 28, 2026

Study Completion (Actual)

April 28, 2026

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7018-03
  • jRCT2021240028 (Registry Identifier: Registry Identifier:)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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