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Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05079282
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE September 30, 2021
First Posted Date  ICMJE October 15, 2021
Last Update Posted Date May 3, 2024
Actual Study Start Date  ICMJE December 10, 2021
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2021)
  • Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). [ Time Frame: Through study completion, an average of 1 year ]
    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.
  • Estimate of Maximum Tolerate Dose (MTD) [ Time Frame: Up to 3 weeks ]
    MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2021)
  • Plasma Concentration of ONO-4685 [ Time Frame: Up to 48 weeks ]
    Plasma concentration will be assessed to evaluate Pharmacokinetics
  • Plasma Concentration of Anti-Drug Antibody (ADA) [ Time Frame: Up to 48 weeks ]
    ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.
  • Antitumor Activity of ONO-4685 [ Time Frame: Through study completion, an average of 1 year ]
    Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Official Title  ICMJE An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma
Brief Summary This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory T Cell Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ONO-4685 monotherapy
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
Intervention: Drug: ONO-4685
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2023)		 217
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2021)		 86
Estimated Study Completion Date  ICMJE June 1, 2026
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Patients aged ≥ 18 years at time of screening
  2. Written informed consent by the patient or the patients' legally authorized representative prior to screening

  3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:

    1. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)
    2. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
  4. Patients must have received at least 2 prior systemic therapies.
  5. Patients with PTCL must have at least 1 measurable lesion
  6. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
  8. Life expectancy of at least 3 months
  9. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

  1. Patients with central nervous system (CNS) involvement
  2. Patients with Adult T-cell leukemia/lymphoma (ATLL)
  3. Prior allogeneic stem cell transplant
  4. Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  5. Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
  6. History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
  7. History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
  8. Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
  9. Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
  10. Women who are pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ono Pharma USA, Inc. clinical_trial@ono-pharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05079282
Other Study ID Numbers  ICMJE ONO-4685-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ono Pharmaceutical Co. Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Project Leader Ono Pharma USA Inc
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP