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

NCT06622226 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: ONO-7018-03jRCT2021240028
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 28 days after the last dose

Secondary Outcomes (15)

• Plasma Concentration of ONO-7018

  up to 16 weeks after the first dose

• Maximum observed concentration (Cmax)

  up to 16 weeks after the first dose

• Time to Cmax (Tmax)

  up to 16 weeks after the first dose

• Area under the concentration-time curve to the end of the dosing period (AUCtau)

  up to 16 weeks after the first dose

• Elimination half-life (T1/2)

  up to 16 weeks after the first dose

Study Arms (1)

Evaluation of Tolerability

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

Interventions

ONO-7018 DRUG

ONO-7018 tablet(s) are administered orally.

Evaluation of Tolerability

Eligibility Criteria

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

You may qualify if:

• 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)
• 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.
• Patient who has measurable disease
• Eastern Cooperative Oncology Group Performance Status 0 to 2
• Life expectancy of at least 3 months

You may not qualify if:

• 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 is unable to swallow tablets

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (6)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Location

National Hospital Organization Shibukawa Medical Center

Shibukawa-shi, Gunma, Japan

Location

Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Location

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6)