Open Actively Recruiting

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 I

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:

  • 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

Join this Trial

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Study Stats
Protocol No.
23-000083
Category
Lymphoma
Contact
Shenetra Walker
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05515406
For detailed technical eligibility, visit ClinicalTrials.gov.