Solid TumorPhase 1NCT06535009
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
A Phase 1 study testing ONO-7914 and ONO-4538 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ONO-7914 and ONO-4538
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteJapan
- Study dates
- 8 Feb 2022to 26 Feb 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced or metastatic solid tumor
- Patients with ECOG performance status of 0 or 1
- Patients with a life expectancy of at least 3 months
Who cannot join
- Patients with severe complication
- Patients judged to be incapable of providing consent for reasons such as concurrent dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors
- Conditions
- Solid Tumor
- Being tested
- ONO-7914, ONO-4538
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7914Drug
Specified dose on specified days
ONO-4538Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7914 | Experimental | Not described Receives: Drug: ONO-7914 |
| ONO-7914+ONO-4538 | Experimental | Not described Receives: Drug: ONO-7914; Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: 28 days
Adverse Events as assessed by CTCAE v5.0
Measured: Up to 28 days after the completion of treatment period
Secondary outcomes (3)
Plasma concentration of ONO-7914
Measured: Up to 21 days after the first treatment
Urine concentration of ONO-7914
Measured: Up to 24 hours after the first treatment
Serum concentration of ONO-4538
Measured: Up to 28 days after the completion of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start8 Feb 2022
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Why it stopped: Due to strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT06535009
- Sponsor's protocol ID
- ONO-7914-01
- Status last verified
- May 2025
- First submitted
- 21 Jul 2024
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06535009
- Acronym / sponsor ID
- ONO-7914-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to strategic reasons
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 2 Aug 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.
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-7914 | Experimental | Drug: ONO-7914 |
| ONO-7914+ONO-4538 | Experimental | Drug: ONO-7914, Drug: ONO-4538 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with advanced or metastatic solid tumor
- Patients with ECOG performance status of 0 or 1
- Patients with a life expectancy of at least 3 months
Key exclusion criteria (2 listed)
- Patients with severe complication
- Patients judged to be incapable of providing consent for reasons such as concurrent dementia
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-7914Specified dose on specified days | Drug | ONO-7914, ONO-7914+ONO-4538 |
| ONO-4538Specified dose on specified days | Drug | ONO-7914+ONO-4538 |
Primary outcome
Dose Limiting Toxicity
Time frame: 28 days
Adverse Events as assessed by CTCAE v5.0
Time frame: Up to 28 days after the completion of treatment period
3 secondary outcomes
Plasma concentration of ONO-7914
Time frame: Up to 21 days after the first treatment
Urine concentration of ONO-7914
Time frame: Up to 24 hours after the first treatment
Serum concentration of ONO-4538
Time frame: Up to 28 days after the completion of treatment period
Results and safety
The study was stopped early (reason given: Due to strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- 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.
1 site 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-7914 and ONO-4538 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site 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 3 inclusion and 2 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Due to strategic reasons). 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 Toxicity (time frame: 28 days). 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 4 Jun 2025.