NCT05515406TerminatedPhase 1
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL
Source: ClinicalTrials.gov · Last updated 29 May 2026
Reason given: The study was terminated due to a strategic decision to discontinue development.
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 18 Aug 2022
- Start date
- 13 Feb 2023
- Primary completion date
- 13 Aug 2025
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05515406
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a MALT1 inhibitor
- Patient receiving any other investigational drug within 4 weeks prior to study entry
Other illness
- History of lymphoid malignancy other than those allowed per inclusion criteria
- 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
Other
- Patient with central nervous system involvement
- Patient is unable to swallow tablets
- Patient is found to be otherwise ineligible for the study by the investigator or sub investigator
Who the study is looking for
- 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
- Adequate bone marrow, renal and hepatic functions
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cincinnati | Cincinnati | United States | Unknown status |
| Baylor Scott & White Research Institute | Dallas | United States | Unknown status |
| Summit Medical Group | Florham Park | United States | Unknown status |
| Leo Jenkins Cancer Center/ECU School of Medicine | Greenville | United States | Unknown status |
| MD Anderson Cancer Center | Houston | United States | Unknown status |
| AMR Kansas City | Kansas City | United States | Unknown status |
| Sarah Cannon Research Institute | Nashville | United States | Unknown status |
| University of Pennsylvania | Philadelphia | United States | Unknown status |
| Thomas Jefferson University | Philadelphia | United States | Unknown status |
| Jonsson Comprehensive Cancer Center | Santa Monica | United States | Unknown status |
| Northwest Medical Specialities | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.