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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Non Hodgkin Lymphoma

Treatments: Drug: ONO-7018

Study type: Interventional

Funder types: Industry

Identifiers

NCT06622226

jRCT2021240028 (Registry Identifier)

ONO-7018-03

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Evaluation of Tolerability

Experimental group

Description:

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.

Treatment:

Drug: ONO-7018