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A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

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: NCT05515406
Recruitment Status : Recruiting
First Posted : August 25, 2022
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE August 18, 2022
First Posted Date  ICMJE August 25, 2022
Last Update Posted Date February 17, 2023
Actual Study Start Date  ICMJE February 13, 2023
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
  • Estimate of Maximum Tolerated 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
  • Incidence, causality, 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
  • Plasma Concentration of ONO-7018 [ Time Frame: Up to 48 weeks ]
    Plasma concentration will be assessed to evaluate Pharmacokinetics
  • Antitumor Activity of ONO-7018 (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.Lymphoma.
  • Antitumor Activity of ONO-7018 (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.
  • Antitumor Activity of ONO-7018 (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.
  • Antitumor Activity of ONO-7018 (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.
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 A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL
Official Title  ICMJE A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL
Brief Summary This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).
Detailed Description ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL and CLL. The purpose of this study is to determine the MTD and to evaluate the safety, tolerability, PK, pharmacodynamics (biomarkers), and efficacy of ONO-7018 in patients with relapsed or refractory NHL or CLL.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
Intervention  ICMJE Drug: ONO-7018
ONO-7018 tablet(s) are administered orally
Study Arms  ICMJE
  • Experimental: Dose Escalation Phase (Part 1)
    Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.
    Intervention: Drug: ONO-7018
  • Experimental: Dose Expansion Phase (Part 2)
    Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.
    Intervention: Drug: ONO-7018
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 23, 2022)		 54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient aged ≥ 18 years
  2. Written informed consent by the patient or the patient's legally authorized representative
  3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
  4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
  5. Patient who has measurable disease
  6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
  7. Eastern Cooperative Oncology Group Performance Status 0 to 2
  8. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

  1. History of lymphoid malignancy other than those allowed per inclusion criteria
  2. Patient with central nervous system involvement
  3. Patient with systemic and active infection
  4. 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
  5. Prior treatment with a MALT1 inhibitor
  6. Patient receiving any other investigational drug within 4 weeks prior to study entry
  7. Patient is unable to swallow tablets
  8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator
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 NCT05515406
Other Study ID Numbers  ICMJE ONO-7018-01
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: Yes
URL: https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html
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 February 2023

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