A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors (NCT06816108) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Japan35 participantsStarted 2025-04-21
Plain-language summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
. Participants who are refractory or intolerant to standard therapy.
. 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.
. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
. Participants with tumor tissue samples available for biomarker testing.
Exclusion criteria
. Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
. Participants with severe peritoneal dissemination.
. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
. Participants with uncontrolled tumor-related pain.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ONO-7428 is in Phase 1 and the main goal is to find a safe dose and measure side effects, what does that mean for my personal risk compared to already-approved treatments for my solid tumor or NSCLC?
2This trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — can you help me find out if there's a related or follow-up study I might actually be eligible for?
3Because Phase 1 trials focus on dose-limiting toxicities and adverse events rather than proving the drug works, how would we measure whether this treatment is helping me, and what would the plan be if it isn't?
4Given that this is a first-in-human type study measuring how the body tolerates ONO-7428, would you recommend I try any standard-of-care options first before considering an experimental Phase 1 trial like this one?
5If I had been eligible for this trial, what kinds of side effects or dose-related risks would you have wanted me to understand before deciding, based on how drugs in this class typically behave?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.