Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around

Description

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).

Official Title

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

Details

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.

Keywords

Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia, Non-Hodgkin Lymphoma, Lymphoid Leukemia, ONO-7018

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient aged ≥ 18 years
  2. Written informed consent by the patient or the patient's legally authorized representative
  3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
  4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
  5. Patient who has measurable disease
  6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
  7. Eastern Cooperative Oncology Group Performance Status 0 to 2
  8. Adequate bone marrow, renal and hepatic functions

You CAN'T join if...

  1. History of lymphoid malignancy other than those allowed per inclusion criteria
  2. Patient with central nervous system involvement
  3. Patient with systemic and active infection
  4. 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
  5. Prior treatment with a MALT1 inhibitor
  6. Patient receiving any other investigational drug within 4 weeks prior to study entry
  7. Patient is unable to swallow tablets
  8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

Locations

  • Jonsson Comprehensive Cancer Center accepting new patients
    Santa Monica California 90404 United States
  • Baylor Scott & White Research Institute accepting new patients
    Dallas Texas 75246 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ono Pharmaceutical Co. Ltd
ID
NCT05515406
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated