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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: ONO-4685

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745(Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777(Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan
      • Recruiting
      • Aichi Cancer Center Hospital
    • Nagoya-shi, Aichi, Japan
      • Recruiting
      • Nagoya University Hospital
  • Akita
    • Akita-shi, Akita, Japan
      • Recruiting
      • Akita University Hospital
  • Chiba
    • Kashiwa-shi, Chiba, Japan
      • Recruiting
      • National Cancer Center Hospital East
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
      • Recruiting
      • Kyushu University Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
      • Recruiting
      • Hokkaido University Hospital
  • Kanagawa
    • Isehara-shi, Kanagawa, Japan
      • Recruiting
      • Tokai University Hospital
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan
      • Recruiting
      • Kumamoto University Hospital
  • Kyoto
    • Kyoto-shi, Kyoto, Japan
      • Recruiting
      • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi
    • Sendai-shi, Miyagi, Japan
      • Recruiting
      • Tohoku University Hospital
  • Okayama
    • Okayama-shi, Okayama, Japan
      • Recruiting
      • Okayama University Hospital
  • Osaka
    • Osaka Sayama-shi, Osaka, Japan
      • Recruiting
      • Kindai University Hospital
    • Osaka-fu, Osaka, Japan
      • Not yet recruiting
      • Osaka University Hospital
  • Tokyo
    • Koto-ku, Tokyo, Japan
      • Recruiting
      • Cancer Institute Hospital of JFCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. 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
3. ECOG PS 0~2
4. Life expectancy of at least 3 months

Exclusion Criteria:

1. Patients with severe complications.
2. Patients with multiple cancers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4685	Drug: ONO-4685; ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Time to response (TTR)	Through study completion, an average of 1 year
Overall Survival(OS)	Through study completion, an average of 1 year
The percent change of tumor volume	Through study completion, an average of 1 year
Pharmacokinetics(Cmax)	Through study completion, an average of 1 year
Pharmacokinetics(Tmax)	Through study completion, an average of 1 year
Pharmacokinetics(AUC)	Through study completion, an average of 1 year
Pharmacokinetics(Ceoi)	Through study completion, an average of 1 year
Pharmacokinetics(T1/2)	Through study completion, an average of 1 year
Pharmacokinetics(Ctrough)	Through study completion, an average of 1 year
Volume of distribution(Vd)	Through study completion, an average of 1 year
clearance(CL)	Through study completion, an average of 1 year
Anti-ONO-4685 antibody	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia; Lymphoma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: ONO-4685-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No