NCT06816108 A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
| NCT ID | NCT06816108 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-04-21 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Eligibility 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.
Contact & Investigator
Project Leader
STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT06816108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06816108 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06816108 currently recruiting?
Yes, NCT06816108 is actively recruiting participants. Contact the research team at clinical_trial@ono-pharma.com for enrollment information.
Where is the NCT06816108 trial being conducted?
This trial is being conducted at Nagoya, Japan, Kashiwa, Japan, Kurume, Japan, Nishinomiya, Japan and 11 additional locations.
Who is sponsoring the NCT06816108 clinical trial?
NCT06816108 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Project Leader at Ono Pharmaceutical Co., Ltd.. The trial plans to enroll 60 participants.