Non Hodgkin Lymphoma Clinical Trial
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
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).
ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL and CLL. The purpose of this study is to determine the MTD and to evaluate the safety, tolerability, PK, pharmacodynamics (biomarkers), and efficacy of ONO-7018 in patients with relapsed or refractory NHL or CLL.
Patient aged â‰¥ 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 â‰¤ 1 before the start of study therapy
Eastern Cooperative Oncology Group Performance Status 0 to 2
Adequate bone marrow, renal and hepatic functions
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
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There are 10 Locations for this study
Santa Monica California, 90404, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02215, United States
Greenville North Carolina, 27858, United States
Cincinnati Ohio, 45267, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Dallas Texas, 75246, United States
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