Evaluating ONO-7428 for advanced solid tumors
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 testing a new drug called ONO-7428 to see if it is safe and helpful for people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 15 sites (Nagoya, Aichi-ken and 14 other locations) |
| Trial ID | NCT06816108 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of ONO-7428 in patients with unresectable advanced or recurrent solid tumors, including non-small cell lung cancer (NSCLC). Participants must have confirmed diagnoses and be refractory or intolerant to standard therapies. The study aims to gather data on the drug's effects and potential benefits for these patients. Tumor tissue samples will be collected for biomarker testing to further understand treatment responses.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresectable advanced or recurrent solid tumors who have previously received anti-PD-(L)1 antibody treatments.
Not a fit: Patients with severe autoimmune diseases or those who have had severe hypersensitivity reactions to antibody drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Participants who are refractory or intolerant to standard therapy. 3. 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. 4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 5. Participants with tumor tissue samples available for biomarker testing. Exclusion Criteria: 1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs. 2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 3. Participants with severe peritoneal dissemination. 4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment. 5. Participants with uncontrolled tumor-related pain. 6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Where this trial is running
Nagoya, Aichi-ken and 14 other locations
- Nagoya University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (Recruiting)
- Kurume University Hospital — Kurume, Fukuoka, Japan (Recruiting)
- Hyogo Medical University Hospital — Nishinomiya, Hyōgo, Japan (Recruiting)
- Kitasato University Hospital — Sagamihara, Kanagawa, Japan (Recruiting)
- Kanagawa Cancer Center — Yokohama, Kanagawa, Japan (Recruiting)
- Kochi Medical School Hospital — Nankoku, Kochi, Japan (Recruiting)
- Kyoto University Hospital — Kyoto, Kyoto, 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)
- Saitama Medical University International Medical Center — Hidaka, Saitama, Japan (Recruiting)
- Saitama Cancer Center — Shinden, Saitama, Japan (Recruiting)
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital — Bunkyō-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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.