Solid TumorPhase 1NCT06816108
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
A Phase 1 study testing ONO-7428 in people with Solid Tumor and NSCLC, run by Ono Pharmaceutical Co., Ltd. at 15 sites in Japan.
Trial summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, NSCLC
- What is being tested?
- ONO-7428
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 15 sitesJapan
- Study dates
- 21 Apr 2025to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- [Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.
- Participants who are refractory or intolerant to standard therapy.
- Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
- Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Participants with tumor tissue samples available for biomarker testing.
Who cannot join
- Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
- Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- Participants with severe peritoneal dissemination.
- Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
- Participants with uncontrolled tumor-related pain.
- Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo
Saitama Medical University International Medical Center
Hidaka, Saitama
Kansai Medical University Hospital
Hirakata, Osaka
National Cancer Center Hospital East
Kashiwa, Chiba
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo
Kurume University Hospital
Kurume, Fukuoka
Kyoto University Hospital
Kyoto, Kyoto
Nagoya University Hospital
Nagoya, Aichi-ken
Kochi Medical School Hospital
Nankoku, Kochi
Hyogo Medical University Hospital
Nishinomiya, Hyōgo
Osaka International Cancer Institute
Osaka, Osaka
Kitasato University Hospital
Sagamihara, Kanagawa
Kindai University Hospital
Sakai, Osaka
Saitama Cancer Center
Shinden, Saitama
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
Official title: A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
- Conditions
- Solid Tumor, NSCLC
- Being tested
- ONO-7428
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7428Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7428 | Experimental | Not described Receives: Drug: ONO-7428 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities（DLT）
Measured: 21 days
Adverse event (AE)
Measured: Up to 2 years
Secondary outcomes (13)
Cmax
Measured: Up to 2 years
Tmax
Measured: Up to 2 years
Area under the Plasma Concentration versus Time Curve (AUC)
Measured: Up to 2 years
Ctrough
Measured: Up to 2 years
Objective Response Rate (ORR)
Measured: Up to 2 years
Disease Control Rate (DCR)
Measured: Up to 2 years
Overall Survival (OS)
Measured: Up to 2 years
Progression-Free Survival (PFS)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Time to Response (TTR)
Measured: Up to 2 years
Best Overall Response (BOR)
Measured: Up to 2 years
Percent change from baseline in the sum of diameters of target lesions
Measured: Up to 2 years
Best reduction percent change from baseline in the sum of diameters of target lesions
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start21 Apr 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT06816108
- Sponsor's protocol ID
- ONO-7428-01
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2025
- Last updated
- 5 Aug 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 5 Aug 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 Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT06816108
- Acronym / sponsor ID
- ONO-7428-01
- Conditions
- Solid Tumor, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Feb 2025 (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 to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-7428 | Experimental | Drug: ONO-7428 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- [Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.
- Participants who are refractory or intolerant to standard therapy.
- Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
- Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
Key exclusion criteria (6 listed)
- Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
- Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- Participants with severe peritoneal dissemination.
- Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
- Participants with uncontrolled tumor-related pain.
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-7428Specified dose on specified days | Drug | ONO-7428 |
Primary outcome
Dose-limiting toxicities（DLT）
Time frame: 21 days
Adverse event (AE)
Time frame: Up to 2 years
13 secondary outcomes
Cmax
Time frame: Up to 2 years
Tmax
Time frame: Up to 2 years
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame: Up to 2 years
Ctrough
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Time to Response (TTR)
Time frame: Up to 2 years
Best Overall Response (BOR)
Time frame: Up to 2 years
Percent change from baseline in the sum of diameters of target lesions
Time frame: Up to 2 years
Best reduction percent change from baseline in the sum of diameters of target lesions
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
15 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-7428 in people with Solid Tumor and NSCLC, run by Ono Pharmaceutical Co., Ltd. at 15 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
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（DLT） (time frame: 21 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 5 Aug 2026.