Lymphoma, Non-HodgkinPhase 1NCT05515406
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
A Phase 1 study testing ONO-7018 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Ono Pharmaceutical Co., Ltd. at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- ONO-7018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 Feb 2023to 13 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- Written informed consent by the patient or the patient's legally authorized representative
- Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
- Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
- Patient who has measurable disease
- All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Adequate bone marrow, renal and hepatic functions
Who cannot join
- History of lymphoid malignancy other than those allowed per inclusion criteria
- Patient with central nervous system involvement
- Patient with systemic and active infection
- 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
- Prior treatment with a MALT1 inhibitor
- Patient receiving any other investigational drug within 4 weeks prior to study entry
- Patient is unable to swallow tablets
- Patient is found to be otherwise ineligible for the study by the investigator or sub investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Summit Medical Group
Florham Park, New Jersey, 07932
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, 27858
MD Anderson Cancer Center
Houston, Texas, 77030
AMR Kansas City
Kansas City, Missouri, 64114
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404
Northwest Medical Specialities
Tacoma, Washington, 98405
About this study
Official title: 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).
Read the 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.
- Being tested
- ONO-7018
- Keywords
- ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7018Drug
ONO-7018 tablet(s) are administered orally
ONO-7018Drug
ONO-7018 tablet(s) are administered orally
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase (Part 1) | Experimental | 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. Receives: Drug: ONO-7018 |
| Dose Expansion Phase (Part 2) | Experimental | Eligible patients will be assigned to the recommended dose level(s) selected from Part 1. Receives: Drug: ONO-7018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of Maximum Tolerated Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Measured: Up to 3 weeks
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Plasma Concentration of ONO-7018
Plasma concentration will be assessed to evaluate Pharmacokinetics
Measured: Up to 48 weeks
Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])
Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.Lymphoma.
Measured: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Duration of Response [DOR])
Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.
Measured: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])
Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.
Measured: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Overall Survival [OS])
Antitumor activity of ONO-7018 as measured by OS will be assessed.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start13 Feb 2023
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Why it stopped: The study was terminated due to a strategic decision to discontinue development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharma USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515406
- Sponsor's protocol ID
- ONO-7018-01
- Status last verified
- May 2026
- First submitted
- 18 Aug 2022
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05515406
- Acronym / sponsor ID
- ONO-7018-01
- Keywords
- ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to a strategic decision to discontinue development.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase (Part 1) | Experimental | Drug: ONO-7018Up 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. |
| Dose Expansion Phase (Part 2) | Experimental | Drug: ONO-7018Eligible patients will be assigned to the recommended dose level(s) selected from Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged ≥ 18 years
- Written informed consent by the patient or the patient's legally authorized representative
- Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
- Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
- Patient who has measurable disease
Key exclusion criteria (8 listed)
- History of lymphoid malignancy other than those allowed per inclusion criteria
- Patient with central nervous system involvement
- Patient with systemic and active infection
- 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
- Prior treatment with a MALT1 inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-7018ONO-7018 tablet(s) are administered orally | Drug | Dose Escalation Phase (Part 1) |
| ONO-7018ONO-7018 tablet(s) are administered orally | Drug | Dose Expansion Phase (Part 2) |
Primary outcome
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
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.
5 secondary outcomes
Plasma Concentration of ONO-7018
Time frame: 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 (Duration of Response [DOR])
Time frame: 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 (Overall Survival [OS])
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: The study was terminated due to a strategic decision to discontinue development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharma USA Inc
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-7018 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Ono Pharmaceutical Co., Ltd. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to a strategic decision to discontinue development.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of Maximum Tolerated Dose (MTD) (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.