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

NCT06547528 | Recruiting Phase 1 DMC

• 1 other identifier: ONO-4685-05
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (14)

• Dose-limiting toxicities(DLT)

  Up to 3 Weeks

• Incidence and severity of AEs and SAEs

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• Body temperature

  Through study completion, an average of 1 year

• Pulse rate

  Through study completion, an average of 1 year

• Systolic/diastolic blood pressure

  Through study completion, an average of 1 year

• Change of weight during the trial period

  Through study completion, an average of 1 year

• Chest X-ray test

  Through study completion, an average of 1 year

• ECG parameters by 12 lead ECG(pulse rate)

  Through study completion, an average of 1 year

• ECG parameters by 12 lead ECG(RR)

  Through study completion, an average of 1 year

• ECG parameters by 12 lead ECG(QT interval)

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• ECG parameters by 12 lead ECG(PR interval)

  Through study completion, an average of 1 year

• ECG parameters by 12 lead ECG(QRS)

  Through study completion, an average of 1 year

Secondary Outcomes (17)

• Best overall response (BOR)

  Through study completion, an average of 1 year

• Overall response rate (ORR)

  Through study completion, an average of 1 year

• Complete response rate (CRR)

  Through study completion, an average of 1 year

• Duration of response (DOR)

  Through study completion, an average of 1 year

• Progression Free Survival(PFS)

  Through study completion, an average of 1 year

Study Arms (1)

ONO-4685

EXPERIMENTAL

Drug: ONO-4685

Interventions

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.

ONO-4685

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (14)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

Akita University Hospital

Akita, Akita, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, Japan

RECRUITING

Kindai University Hospital

Osaka Sayama-shi, Osaka, Japan

RECRUITING

Osaka University Hospital

Osaka-fu, Osaka, Japan

NOT YET RECRUITING

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

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: August 1, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (14)