Solid TumorsPhase 1NCT07787208
A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
A Phase 1 study testing ONO-7429 in people with Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 10 sites in Japan.
Trial summary
This study is to evaluate the tolerability and safety of ONO-7429 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 Tumors
- What is being tested?
- ONO-7429
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesJapan
- Study dates
- 19 Jun 2026to Mar 2030
- 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.
- Participants who are refractory or intolerant to standard therapy.
- 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 history or presence of severe hypersensitivity to any other antibody agents.
- Participants with pericardial fluid, pleural effusion or ascites requiring treatment
- Participants with uncontrolled tumor-related pain
- Participants with severe peritoneal dissemination.
- Participants with multiple primary cancers.
- Participants with a history or presence of ILD or pulmonary fibrosis.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
10 sites in 1 country
Japan10 sites, 10 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
- Recruiting
Gunma University Hospital
Maebashi, Gunma
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka
- Recruiting
Kindai University Hospital
Sakai, Osaka
- Recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka
About this study
Official title: A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety and Tolerability of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
This study is to evaluate the tolerability and safety of ONO-7429 in participants with unresectable advanced or recurrent solid tumors.
- Conditions
- Solid Tumors
- Being tested
- ONO-7429
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7429Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7429 | Experimental | Not described Receives: Drug: ONO-7429 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities（DLT）
Measured: From first dose through completion of the DLT evaluation period (approximately 21 days)
Adverse event (AE)
Measured: Approximately 6 months
Secondary outcomes (16)
Area under the Plasma Concentration versus Time Curve (AUC)
Measured: Approximately 6 months
Cmax
Measured: Approximately 6 months
Tmax
Measured: Approximately 6 months
Terminal elimination half-life（T1/2）
Measured: Approximately 6 months
Ctrough
Measured: Approximately 6 months
CL
Measured: Approximately 6 months
Volume of distribution at steady state（Vss）
Measured: Approximately 6 months
Objective Response Rate (ORR)
Measured: Approximately 6 months
Disease Control Rate (DCR)
Measured: Approximately 6 months
Best overall response（BOR）
Measured: Approximately 6 months
Duration of Response (DOR)
Measured: Approximately 6 months
Progression-Free Survival (PFS)
Measured: Approximately 6 months
Overall Survival (OS)
Measured: Approximately 6 months
Time to Response (TTR)
Measured: Approximately 6 months
Percent change from baseline in the sum of diameters of target lesions
Measured: Approximately 6 months
Best percent change from baseline in the sum of diameters of target lesions
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start19 Jun 2026
- Primary completionJul 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 80 participants (estimated)
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
- NCT07787208
- Sponsor's protocol ID
- ONO-7429-01
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- 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 26 Aug 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 and Tolerability of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT07787208
- Acronym / sponsor ID
- ONO-7429-01
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 26 Aug 2026 (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-7429 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-7429 | Experimental | Drug: ONO-7429 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- Participants who are refractory or intolerant to standard therapy.
- Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
- Participants with tumor tissue samples available for biomarker testing.
Key exclusion criteria (6 listed)
- Participants with a history or presence of severe hypersensitivity to any other antibody agents.
- Participants with pericardial fluid, pleural effusion or ascites requiring treatment
- Participants with uncontrolled tumor-related pain
- Participants with severe peritoneal dissemination.
- Participants with multiple primary cancers.
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-7429Specified dose on specified days | Drug | ONO-7429 |
Primary outcome
Dose-limiting toxicities（DLT）
Time frame: From first dose through completion of the DLT evaluation period (approximately 21 days)
Adverse event (AE)
Time frame: Approximately 6 months
16 secondary outcomes
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame: Approximately 6 months
Cmax
Time frame: Approximately 6 months
Tmax
Time frame: Approximately 6 months
Terminal elimination half-life（T1/2）
Time frame: Approximately 6 months
Ctrough
Time frame: Approximately 6 months
CL
Time frame: Approximately 6 months
Volume of distribution at steady state（Vss）
Time frame: Approximately 6 months
Objective Response Rate (ORR)
Time frame: Approximately 6 months
Disease Control Rate (DCR)
Time frame: Approximately 6 months
Best overall response（BOR）
Time frame: Approximately 6 months
Duration of Response (DOR)
Time frame: Approximately 6 months
Progression-Free Survival (PFS)
Time frame: Approximately 6 months
Overall Survival (OS)
Time frame: Approximately 6 months
Time to Response (TTR)
Time frame: Approximately 6 months
Percent change from baseline in the sum of diameters of target lesions
Time frame: Approximately 6 months
Best percent change from baseline in the sum of diameters of target lesions
Time frame: Approximately 6 months
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 26 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.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
10 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-7429 in people with Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 10 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 4 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: looking for participants now, as of the sponsor's last update on 26 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 10 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?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities（DLT） (time frame: From first dose through completion of the DLT evaluation period (approximately 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 26 Aug 2026.