We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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

Layout table for study information
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

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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

Layout table for location information
Local Institution
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Layout table for investigator information
Study Chair: Kazuhiro Nakabayashi Ono Pharmaceutical Co. Ltd
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No