A phase 1 study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ONO-7018 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) in Japan

JRCT ID: jRCT2021240028

Registered date:03/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Hodgkin Lymphoma
• Date of first enrollment: 25/11/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): ONO-7018 Given as Monotherapy

Outcome(s)

• Primary Outcome: To assess the tolerability and safety of ONO-7018 in patients with relapsed or refractory NHL

Secondary Outcome

To assess the efficacy of ONO-7018 in patients with relapsed or refractory NHL
To assess the PK profile of ONO-7018

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.ECOG PS 0 to 2
5.Life expectancy of at least 3 months

Exclude 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

Related Information

• Primary Sponsor: Terasawa Tetsuji
• Secondary ID(s): NCT06622226