A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1TerminatedNCT06622226

Ono Pharmaceutical Co., Ltd.2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Hodgkin Lymphoma

Interventions

ONO-7018DRUG

ONO-7018 tablet(s) are administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa-shi, Gunma, Japan

Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Outcomes

Primary Outcomes

Dose-limiting toxicities

Observed toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 to assess the tolerability of ONO-7018.

Time frame: up to 3 weeks after the first dose

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: Up to 28 days after the last dose