ONO-7429 in advanced or recurrent solid tumors
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
Run by Ono Pharmaceutical Co., Ltd. · NCT07787208 · Data updated 2026-11-12
This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 10 sites (Kashiwa, Chiba and 9 other locations) |
| Status | Recruiting |
| Started | June 19, 2026 |
| Main results expected | July 2028 |
| Study ends | March 2030 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07787208 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors, who have exhausted standard therapy or cannot tolerate it, with good performance status (ECOG 0-1) and available tumor tissue for biomarker testing.
✕Probably not a fit
Patients with severe comorbidities, poor performance status, uncontrolled tumor-related symptoms, or biomarkers suggesting low likelihood of response may receive no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 1 trial evaluating the safety and tolerability of ONO-7429 in participants with unresectable advanced or recurrent solid tumors. Eligible patients must have good performance status, have tumor tissue available for biomarker testing, and have exhausted standard therapies or cannot tolerate them. Participants will receive ONO-7429 and be monitored for safety, with preliminary signals of activity explored. The study is conducted at three Japanese centers and is sponsored by Ono Pharmaceutical Co., Ltd. Biomarker data may help identify subgroups that respond best.
Why it matters
Potential benefit: If successful, participants may experience disease stabilization or tumor shrinkage and gain information that could guide future studies.
How similar studies have gone: Early-phase studies in similar targets have shown safety signals and potential activity in solid tumors, but outcomes in this specific approach remain exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing. Exclusion Criteria: 1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.
Where it's running
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National Cancer Center Hospital East
Kashiwa, Chiba, Japan Recruiting -
Gunma University Hospital
Maebashi, Gunma, Japan Recruiting -
Niigata Cancer Center Hospital
Niigata, Niigata, Japan Recruiting -
Kansai Medical University Hospital
Hirakata, Osaka, Japan Recruiting -
Osaka International Cancer Institute
Osaka, Osaka, Japan Recruiting -
Kindai University Hospital
Sakai, Osaka, Japan Recruiting
Show 4 more locations
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Saitama Medical University International Medical Center
Hidaka, Saitama, Japan Recruiting -
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan Recruiting -
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan Recruiting -
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.