Testing ONO-4538HSC in patients with advanced solid tumors
An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
This study is testing a new treatment called ONO-4538HSC to see if it is safe and effective for people with advanced solid tumors who haven't had success with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co. Ltd Industry-sponsored |
| Drugs / interventions | nivolumab |
| Locations | 8 sites (Kashiwa-shi, Chiba and 7 other locations) |
| Trial ID | NCT06548217 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open-label, uncontrolled phase I study aimed at evaluating the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously to participants with advanced or metastatic solid tumors. The study includes a tolerability confirmation part to determine the recommended dose for Japanese participants by assessing dose-limiting toxicities (DLTs), and an expansion part to further evaluate safety and pharmacokinetics while exploring efficacy. The study targets patients who are refractory or intolerant to standard therapies or for whom no standard therapies are available.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic solid tumors who have an ECOG performance status of 0 to 1 and a life expectancy of at least 3 months.
Not a fit: Patients with severe complications or a history of severe hypersensitivity to any antibody product may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced or metastatic solid tumors who have limited alternatives.
How similar studies have performed: Other studies have shown success with similar approaches in treating advanced solid tumors, indicating potential for this novel treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with advanced or metastatic solid tumors 2. Patients have an ECOG performance status of 0 to 1 3. Patients with a life expectancy of at least 3 months \[Tolerability confirmation part\] 4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available \[Expansion part\] 5. Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert Exclusion Criteria: 1. Patients with a complication or history of severe hypersensitivity to any antibody product 2. Patients with severe complication
Where this trial is running
Kashiwa-shi, Chiba and 7 other locations
- National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (Recruiting)
- Tohoku University Hospital — Sendai-shi, Miyagi, Japan (Recruiting)
- Niigata Cancer Center Hospital — Niigata-shi, Niigata, Japan (Recruiting)
- Osaka International Cancer Institute — Osaka-shi, Osaka, Japan (Recruiting)
- Kindai University Hospital — Osakasayama-shi, Osaka, 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: Ono Pharmaceutical Co., Ltd.
- Email: clinical_trial@ono-pharma.com
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.