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NCT Number: NCT06547528

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

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Key information

Conditions

Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi Cancer Center 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

  • Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:

Peripheral T-cell lymphoma(PTCL)

  • Angioimmunoblastic T-cell lymphoma(AITL)
  • Peripheral T-cell lymphoma, NOS(PTCL-NOS)
  • Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
  • Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
  • Mycosis fungoides(MF)
  • Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
  • Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
  • ECOG PS 0~2
  • Life expectancy of at least 3 months

Exclusion criteria

  • Patients with severe complications.
  • Patients with multiple cancers.

Treatment and study plan

ONO-4685

Drug

ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.

Primary outcomes

  1. Dose-limiting toxicities(DLT)

    Time frame: Up to 3 Weeks

  2. Incidence and severity of AEs and SAEs

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

  3. Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities

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

  4. Body temperature

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

  5. Pulse rate

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

  6. Systolic/diastolic blood pressure

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

  7. Change of weight during the trial period

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

  8. Chest X-ray test

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

  9. ECG parameters by 12 lead ECG(pulse rate)

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

  10. ECG parameters by 12 lead ECG(RR)

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

  11. ECG parameters by 12 lead ECG(QT interval)

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

  12. ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])

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

  13. ECG parameters by 12 lead ECG(PR interval)

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

  14. ECG parameters by 12 lead ECG(QRS)

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

Secondary outcomes

  1. Best overall response (BOR)

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

  2. Overall response rate (ORR)

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

  3. Complete response rate (CRR)

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

  4. Duration of response (DOR)

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

  5. Progression Free Survival(PFS)

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

  6. Time to response (TTR)

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

  7. Overall Survival(OS)

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

  8. The percent change of tumor volume

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

  9. Pharmacokinetics(Cmax)

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

  10. Pharmacokinetics(Tmax)

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

  11. Pharmacokinetics(AUC)

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

  12. Pharmacokinetics(Ceoi)

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

  13. Pharmacokinetics(T1/2)

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

  14. Pharmacokinetics(Ctrough)

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

  15. Volume of distribution(Vd)

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

  16. clearance(CL)

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

  17. Anti-ONO-4685 antibody

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

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Aug 9, 2024
Registry last updated
Jun 3, 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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