A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

May 26, 2026 updated by: Ono Pharmaceutical Co., Ltd.

A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL

This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

9

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

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Jonsson Comprehensive Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • AMR Kansas City
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Leo Jenkins Cancer Center/ECU School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialities

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient aged ≥ 18 years
  2. Written informed consent by the patient or the patient's legally authorized representative
  3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
  4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
  5. Patient who has measurable disease
  6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
  7. Eastern Cooperative Oncology Group Performance Status 0 to 2
  8. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

  1. History of lymphoid malignancy other than those allowed per inclusion criteria
  2. Patient with central nervous system involvement
  3. Patient with systemic and active infection
  4. 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
  5. Prior treatment with a MALT1 inhibitor
  6. Patient receiving any other investigational drug within 4 weeks prior to study entry
  7. Patient is unable to swallow tablets
  8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Phase (Part 1)
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
Experimental: Dose Expansion Phase (Part 2)
Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.
Drug: ONO-7018
ONO-7018 tablet(s) are administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate of Maximum Tolerated Dose (MTD)
Time Frame: Up to 3 weeks
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Up to 3 weeks
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration of ONO-7018
Time Frame: Up to 48 weeks
Plasma concentration will be assessed to evaluate Pharmacokinetics
Up to 48 weeks
Antitumor Activity of ONO-7018 (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.Lymphoma.
Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (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
Antitumor Activity of ONO-7018 (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
Antitumor Activity of ONO-7018 (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

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 Pharma USA Inc

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)

February 13, 2023

Primary Completion (Actual)

August 13, 2025

Study Completion (Actual)

August 13, 2025

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7018-01

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

Yes

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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