A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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
Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

1. 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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