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NCT Number: NCT06622226

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
  • Prior treatment with a MALT1 inhibitor
  • Patient is unable to swallow tablets

Treatment and study plan

ONO-7018

Drug

ONO-7018 tablet(s) are administered orally.

Primary outcomes

  1. Dose-limiting toxicities

    Time frame: up to 3 weeks after the first dose

    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.

  2. Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Up to 28 days after the last dose

    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.

Secondary outcomes

  1. Plasma Concentration of ONO-7018

    Time frame: up to 16 weeks after the first dose

    Plasma concentration will be assessed to evaluate Pharmacokinetics.

  2. Maximum observed concentration (Cmax)

    Time frame: up to 16 weeks after the first dose

    To assess the PK profile of ONO-7018

  3. Time to Cmax (Tmax)

    Time frame: up to 16 weeks after the first dose

    To assess the PK profile of ONO-7018

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

    Time frame: up to 16 weeks after the first dose

    To assess the PK profile of ONO-7018

  5. Elimination half-life (T1/2)

    Time frame: up to 16 weeks after the first dose

    To assess the PK profile of ONO-7018

  6. Predose trough concentration (Ctrough)

    Time frame: up to 16 weeks after the first dose

    To assess the PK profile of ONO-7018

  7. Overall Response Rate (ORR)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.

  8. Complete response rate (CRR)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma.

  9. Best overall response (BOR)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma.

  10. Duration of response (DOR)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.

  11. Time to response (TTR)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma.

  12. Progression-free survival (PFS)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.

  13. Overall survival (OS)

    Time frame: through study completion, an average of 1 year

    Antitumor activity of ONO-7018 as measured by OS will be assessed.

  14. Percent change of tumor volume

    Time frame: through study completion, an average of 1 year

    Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.

  15. Maximum percent reduction of tumor volume

    Time frame: through study completion, an average of 1 year

    Maximum percent reduction of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-label, Dose Escalation 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 2, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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