Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
Conditions
Keywords
ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
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).
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.
Interventions
DRUGONO-7018
ONO-7018 tablet(s) are administered orally
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate of Maximum Tolerated Dose (MTD) | Up to 3 weeks | MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment |
| Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Through study completion, an average of 1 year | Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of ONO-7018 | Up to 48 weeks | Plasma concentration will be assessed to evaluate Pharmacokinetics |
| Antitumor Activity of ONO-7018 (Overall Response Rate [ORR]) | Through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.Lymphoma. |
| Antitumor Activity of ONO-7018 (Duration of Response [DOR]) | Through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma. |
| Antitumor Activity of ONO-7018 (Progression Free Survival [PFS]) | Through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma. |
| Antitumor Activity of ONO-7018 (Overall Survival [OS]) | Through study completion, an average of 1 year | Antitumor activity of ONO-7018 as measured by OS will be assessed. |
Countries
United States
Contacts
STUDY_DIRECTORProject Leader
Ono Pharma USA Inc
Outcome results
None listed