Clinical trial NCT05515406: A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
Official title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Keywords: ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Estimate of Maximum Tolerated Dose (MTD)
timeFrame: Up to 3 weeks
measure: Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Plasma Concentration of ONO-7018
timeFrame: Up to 48 weeks
measure: Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])
timeFrame: Through study completion, an average of 1 year
measure: Antitumor Activity of ONO-7018 (Duration of Response [DOR])
timeFrame: Through study completion, an average of 1 year
measure: Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])
timeFrame: Through study completion, an average of 1 year
measure: Antitumor Activity of ONO-7018 (Overall Survival [OS])
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
city: Kansas City
country: United States
facility: AMR Kansas City
state: Missouri
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center/ECU School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialities
state: Washington
Study officials:
affiliation: Ono Pharma USA Inc
name: Project Leader
role: STUDY_DIRECTOR
References: