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ONO-7913 Phase I Study (ONO-7913)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403308
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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Brief Summary:
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: ONO-7913 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
Actual Study Start Date : July 28, 2020
Actual Primary Completion Date : January 13, 2022
Actual Study Completion Date : January 13, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: ONO-7913 as a Single Agent Biological: ONO-7913
ONO-7913 will be administered by intravenous continuous infusion during the designated time.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicities [ Time Frame: 28 days ]
    Number of participants with a DLT

  2. Adverse events [ Time Frame: Up to 24 months ]
    Assessed by the NCI CTCAE v5.0 criteria


Secondary Outcome Measures :
  1. Concentration vs time of ONO-7913 as single dose [ Time Frame: Up to 24 months ]
    PK profile


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
  2. ECOG Performance Status of 0-1
  3. Patients with life expectancy of at least 3 months

Exclusion Criteria:

  1. Patients with multiple cancers
  2. Patients with history of serious allergy
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): NCT04403308


Locations
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Japan
Local Institution
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Chair: Kazuhiro Nakabayashi Ono Pharmaceutical Co. Ltd
More Information
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT04403308    
Other Study ID Numbers: ONO-7913-01
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No