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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell Drug: ONO-7018 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 13, 2023
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: ONO-7018
ONO-7018 tablet(s) are administered orally
Experimental: Dose Expansion Phase (Part 2)
Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.
 Drug: ONO-7018
ONO-7018 tablet(s) are administered orally


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Plasma Concentration of ONO-7018 [ Time Frame: Up to 48 weeks ]
    Plasma concentration will be assessed to evaluate Pharmacokinetics

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05515406


Contacts
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Contact: Ono Pharma USA, Inc. clinical_trial@ono-pharma.com

Locations
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United States, California
Jonsson Comprehensive Cancer Center Not yet recruiting
Santa Monica, California, United States, 90404
United States, Georgia
Emory University Hospital Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Missouri
AMR Kansas City Recruiting
Kansas City, Missouri, United States, 64114
Contact: Jennifer Ross    913-386-7556    jennifer.ross@amrllc.com   
Principal Investigator: Jaswinder Singh, MD         
United States, New Jersey
Summit Medical Group Not yet recruiting
Florham Park, New Jersey, United States, 07932
United States, North Carolina
Leo Jenkins Cancer Center/ECU School of Medicine Not yet recruiting
Greenville, North Carolina, United States, 27858
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Baylor Scott & White Research Institute Not yet recruiting
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Project Leader Ono Pharma USA Inc
More Information
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT05515406    
Other Study ID Numbers: ONO-7018-01
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-7018, MALT1 inhibitor, Lymphoma, Leukemia
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes