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Trial Title:
A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
NCT ID:
NCT06622226
Condition:
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group 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:
Evaluation of Tolerability
Summary:
ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1)
and is expected to exhibit antitumor activity in NHL. This study is Phase1 study to
evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (biomarkers)
and efficacy of ONO-7018 in patients with relapsed or refractory NHL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with histologically/cytologically confirmed diagnosis of any of the subtypes
of B-cell NHL or T-cell NHL defined below as documented by medical records and with
histology based on criteria established by the World Health Organization (Swerdlow
2017)
2. Relapsed or refractory patient who is refractory or intolerant to standard therapy
or for whom, in the opinion of the investigator, there is no appropriate treatment
for the primary disease.
3. Patient who has measurable disease
4. Eastern Cooperative Oncology Group Performance Status 0 to 2
5. Life expectancy of at least 3 months
Exclusion Criteria:
1. 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
2. Patient with malignancies other than lymphoid malignancy allowed per inclusion
criteria
3. Prior treatment with a MALT1 inhibitor
4. Patient is unable to swallow tablets
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nagoya City University Hospital
Address:
City:
Nagoya-shi
Country:
Japan
Facility:
Name:
National Hospital Organization Shibukawa Medical Center
Address:
City:
Shibukawa-shi
Country:
Japan
Facility:
Name:
Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital
Address:
City:
Hiroshima-shi
Country:
Japan
Facility:
Name:
National Hospital Organization Sendai Medical Center
Address:
City:
Sendai-shi
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Koto-ku
Country:
Japan
Facility:
Name:
National Hospital Organization Osaka National Hospital
Address:
City:
Osaka
Country:
Japan
Start date:
October 1, 2024
Completion date:
December 31, 2029
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/NCT06622226
