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

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).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05515406

Recruitment Status:

Recruiting

Sponsor:

Ono Pharmaceutical Co. Ltd

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There are 10 Locations for this study

See Locations Near You

Jonsson Comprehensive Cancer Center
Santa Monica California, 90404, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
AMR Kansas City
Kansas City Missouri, 64114, United States More Info
Jennifer Ross
Contact
913-386-7556
[email protected]
Jaswinder Singh, MD
Principal Investigator
Summit Medical Group
Florham Park New Jersey, 07932, United States More Info
Michelle Mackenzie
Contact
973-436-1755
[email protected]
David Gallinson, DO
Principal Investigator
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville North Carolina, 27858, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States More Info
Nadia Osman
Contact
513-584-2118
[email protected]
John Byrd, M.D.
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Grace Delp
Contact
[email protected]
Stefan Barta, M.D.
Principal Investigator
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Kara Ryan, RN
Contact
215-519-8920
[email protected]
Pierluigi Porcu, M.D.
Principal Investigator
Baylor Scott & White Research Institute
Dallas Texas, 75246, United States More Info
Micah Burch, M.D.
Contact
[email protected]
Micah Burch, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05515406

Recruitment Status:

Recruiting

Sponsor:


Ono Pharmaceutical Co. Ltd

How clear is this clinincal trial information?

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