A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
Stopped early · Phase 1
Conditions studied: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
In brief
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).
Key facts
- Study ID
- NCT05515406
- Run by
- Ono Pharmaceutical Co., Ltd.
- People needed
- 9
- Starts
- 2023-02-13
- Expected to finish
- 2025-08-13
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jonsson Comprehensive Cancer Center — Santa Monica, California, United States
- AMR Kansas City — Kansas City, Missouri, United States
- Summit Medical Group — Florham Park, New Jersey, United States
- Leo Jenkins Cancer Center/ECU School of Medicine — Greenville, North Carolina, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Baylor Scott & White Research Institute — Dallas, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Northwest Medical Specialities — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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