Non Hodgkin LymphomaPhase 1NCT06622226
A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing ONO-7018 in people with Non Hodgkin Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 6 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- 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
- 2 participants
- Where
- 6 sitesJapan
- Study dates
- 27 Nov 2024to 28 Apr 2026
- 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 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)
- 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.
- Patient who has measurable disease
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Life expectancy of at least 3 months
Who cannot join
- 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
- Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
- Prior treatment with a MALT1 inhibitor
- Patient is unable to swallow tablets
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
Nagoya City University Hospital
Nagoya, Aichi-ken
National Hospital Organization Osaka National Hospital
Osaka, Osaka
National Hospital Organization Sendai Medical Center
Sendai, Miyagi
National Hospital Organization Shibukawa Medical Center
Shibukawa-shi, Gunma
About this study
Official title: 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.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- ONO-7018
- Medical subject headings
- Lymphoma, Non-Hodgkin
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Tolerability | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
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.
Measured: 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)
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: Up to 28 days after the last dose
Secondary outcomes (15)
Plasma Concentration of ONO-7018
Plasma concentration will be assessed to evaluate Pharmacokinetics.
Measured: up to 16 weeks after the first dose
Maximum observed concentration (Cmax)
To assess the PK profile of ONO-7018
Measured: up to 16 weeks after the first dose
Time to Cmax (Tmax)
To assess the PK profile of ONO-7018
Measured: up to 16 weeks after the first dose
Area under the concentration-time curve to the end of the dosing period (AUCtau)
To assess the PK profile of ONO-7018
Measured: up to 16 weeks after the first dose
Elimination half-life (T1/2)
To assess the PK profile of ONO-7018
Measured: up to 16 weeks after the first dose
Predose trough concentration (Ctrough)
To assess the PK profile of ONO-7018
Measured: up to 16 weeks after the first dose
Overall Response Rate (ORR)
Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.
Measured: through study completion, an average of 1 year
Complete response rate (CRR)
Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma.
Measured: through study completion, an average of 1 year
Best overall response (BOR)
Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma.
Measured: through study completion, an average of 1 year
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
Time to response (TTR)
Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma.
Measured: through study completion, an average of 1 year
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
Overall survival (OS)
Antitumor activity of ONO-7018 as measured by OS will be assessed.
Measured: through study completion, an average of 1 year
Percent change of tumor volume
Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.
Measured: through study completion, an average of 1 year
Maximum percent reduction of tumor volume
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.
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 posted2 Oct 2024
- Study start27 Nov 2024
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Why it stopped: Sponsor decided to discontinue development of the compound
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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 Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622226
- Sponsor's protocol ID
- ONO-7018-03
- Other IDs
- jRCT2021240028
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06622226
- Acronym / sponsor ID
- ONO-7018-03
- Conditions
- Non Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to discontinue development of the compound
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 2 Oct 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Tolerability | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- 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.
- Patient who has measurable disease
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Life expectancy of at least 3 months
Key exclusion criteria (4 listed)
- 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
- Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
- Prior treatment with a MALT1 inhibitor
- Patient is unable to swallow tablets
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 | Evaluation of Tolerability |
Primary outcome
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.
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.
15 secondary outcomes
Plasma Concentration of ONO-7018
Time frame: up to 16 weeks after the first dose
Maximum observed concentration (Cmax)
Time frame: up to 16 weeks after the first dose
Time to Cmax (Tmax)
Time frame: 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
Elimination half-life (T1/2)
Time frame: up to 16 weeks after the first dose
Predose trough concentration (Ctrough)
Time frame: up to 16 weeks after the first dose
Overall Response Rate (ORR)
Time frame: through study completion, an average of 1 year
Complete response rate (CRR)
Time frame: through study completion, an average of 1 year
Best overall response (BOR)
Time frame: through study completion, an average of 1 year
Duration of response (DOR)
Time frame: through study completion, an average of 1 year
Time to response (TTR)
Time frame: through study completion, an average of 1 year
Progression-free survival (PFS)
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Time frame: through study completion, an average of 1 year
Percent change of tumor volume
Time frame: through study completion, an average of 1 year
Maximum percent reduction of tumor volume
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Sponsor decided to discontinue development of the compound). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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 Pharmaceutical Co., Ltd.
6 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 Non Hodgkin Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 6 sites in Japan.
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 5 inclusion and 4 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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: Sponsor decided to discontinue development of the compound). 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?
Dose-limiting toxicities (time frame: up to 3 weeks after the first dose). 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 Jul 2026.