A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients Wit… (NCT05515406) | Clinical Trial Compass
TerminatedPhase 1
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
Stopped: The study was terminated due to a strategic decision to discontinue development.
United States9 participantsStarted 2023-02-13
Plain-language summary
This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).
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
. Patient aged ≥ 18 years
. Written informed consent by the patient or the patient's legally authorized representative
. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
. Patient who has measurable disease
. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
. Eastern Cooperative Oncology Group Performance Status 0 to 2
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Estimate of Maximum Tolerated Dose (MTD)
Timeframe: Up to 3 weeks
2
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: Through study completion, an average of 1 year
. Adequate bone marrow, renal and hepatic functions
Exclusion criteria
. History of lymphoid malignancy other than those allowed per inclusion criteria
. Patient with central nervous system involvement
. Patient with systemic and active infection
. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results
. Prior treatment with a MALT1 inhibitor
. Patient receiving any other investigational drug within 4 weeks prior to study entry
. Patient is unable to swallow tablets
. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator