A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

NCT05515406 | Terminated Phase 1 FDA Drug

• 1 other identifier: ONO-7018-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 11

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).

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia

Outcome Measures

Primary Outcomes (2)

• Estimate of Maximum Tolerated Dose (MTD)

  MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Plasma Concentration of ONO-7018

  Up to 48 weeks

• Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])

  Through study completion, an average of 1 year

• Antitumor Activity of ONO-7018 (Duration of Response [DOR])

  Through study completion, an average of 1 year

• Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])

  Through study completion, an average of 1 year

• Antitumor Activity of ONO-7018 (Overall Survival [OS])

  Through study completion, an average of 1 year

Study Arms (2)

Dose Escalation Phase (Part 1)

EXPERIMENTAL

Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.

Drug: ONO-7018

Dose Expansion Phase (Part 2)

EXPERIMENTAL

Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.

Drug: ONO-7018

Interventions

ONO-7018 DRUG

ONO-7018 tablet(s) are administered orally

Dose Escalation Phase (Part 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged ≥ 18 years
• Written informed consent by the patient or the patient's legally authorized representative
• Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
• Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
• Patient who has measurable disease
• All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
• Eastern Cooperative Oncology Group Performance Status 0 to 2
• Adequate bone marrow, renal and hepatic functions

You may not qualify if:

• Patient with central nervous system involvement
• Patient with systemic and active infection
• 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
• Prior treatment with a MALT1 inhibitor
• Patient receiving any other investigational drug within 4 weeks prior to study entry
• Patient is unable to swallow tablets
• Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (11)

Jonsson Comprehensive Cancer Center

Santa Monica, California, 90404, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Leo Jenkins Cancer Center/ECU School of Medicine

Greenville, North Carolina, 27858, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Northwest Medical Specialities

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Project Leader

  Ono Pharma USA Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 25, 2022
• Study Start: February 13, 2023
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)