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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Jonsson Comprehensive Cancer Center
Santa Monica, California, United States
AMR Kansas City
Kansas City, Missouri, United States
Summit Medical Group
Florham Park, New Jersey, United States
Estimate of Maximum Tolerated Dose (MTD)
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Time frame: Up to 3 weeks
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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.
Time frame: Through study completion, an average of 1 year
Plasma Concentration of ONO-7018
Plasma concentration will be assessed to evaluate Pharmacokinetics
Time frame: Up to 48 weeks
Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])
Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.Lymphoma.
Time frame: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Duration of Response [DOR])
Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.
Time frame: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])
Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.
Time frame: Through study completion, an average of 1 year
Antitumor Activity of ONO-7018 (Overall Survival [OS])
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Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
Antitumor activity of ONO-7018 as measured by OS will be assessed.
Time frame: Through study completion, an average of 1 year