Trial Title:
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
NCT ID:
NCT05515406
Condition:
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-7018
Description:
ONO-7018 tablet(s) are administered orally
Arm group label:
Dose Escalation Phase (Part 1)
Intervention type:
Drug
Intervention name:
ONO-7018
Description:
ONO-7018 tablet(s) are administered orally
Arm group label:
Dose Expansion Phase (Part 2)
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).
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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
Exclusion Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jonsson Comprehensive Cancer Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karla Largaespada
Phone:
310-633-8400
Email:
klargaespada@mednet.ucla.edu
Investigator:
Last name:
Herbert Eradat, MD
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Withdrawn
Facility:
Name:
AMR Kansas City
Address:
City:
Kansas City
Zip:
64114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Ross
Phone:
913-386-7556
Email:
jennifer.ross@amrllc.com
Investigator:
Last name:
Jaswinder Singh, MD
Email:
Principal Investigator
Facility:
Name:
Summit Medical Group
Address:
City:
Florham Park
Zip:
07932
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Mackenzie
Phone:
973-436-1755
Email:
mmackenzie@summithealth.com
Investigator:
Last name:
David Gallinson, DO
Email:
Principal Investigator
Facility:
Name:
Leo Jenkins Cancer Center/ECU School of Medicine
Address:
City:
Greenville
Zip:
27858
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristen Wooten
Email:
wootenk16@ecu.edu
Investigator:
Last name:
Darla Liles, MD
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nadia Osman
Phone:
513-584-2118
Email:
osmann@ucmail.uc.edu
Investigator:
Last name:
John Byrd, M.D.
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Delp
Email:
grace.delp@pennmedicine.upenn.edu
Investigator:
Last name:
Stefan Barta, M.D.
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kara Ryan, RN
Phone:
215-519-8920
Email:
Kara.Ryan@jefferson.edu
Investigator:
Last name:
Pierluigi Porcu, M.D.
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Baylor Scott & White Research Institute
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Contact:
Last name:
Micah Burch, M.D.
Email:
corchemebmt@bswhealth.org
Investigator:
Last name:
Micah Burch, M.D.
Email:
Principal Investigator
Start date:
February 13, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05515406
