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CompletedNCT04403308Updated May 3, 2024

ONO-7913 Phase I Study (ONO-7913)

A Phase 1 interventional study of ONO-7913 in Solid Tumor, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Ono Pharmaceutical Co. Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

Ono Pharmaceutical Co. Ltd is the lead sponsor of 66 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

Exclusion Criteria:

  1. Patients with multiple cancers
  2. Patients with history of serious allergy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    ONO-7913 as a Single Agent

    Biological: ONO-7913

Interventions

  • BiologicalONO-7913

    ONO-7913 will be administered by intravenous continuous infusion during the designated time.

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicities

    Number of participants with a DLT

    Time frame: 28 days

  2. Adverse events

    Assessed by the NCI CTCAE v5.0 criteria

    Time frame: Up to 24 months

Secondary outcomes

  1. Concentration vs time of ONO-7913 as single dose

    PK profile

    Time frame: Up to 24 months

07

Study locations

1 site
  • Local Institution
    Chuo-ku, Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04403308
Lead sponsor
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
May 27, 2020
Start date
Jul 28, 2020
Primary completion
Jan 13, 2022
Completion
Jan 13, 2022
Last update
May 3, 2024

Study contacts

Kazuhiro Nakabayashi
study chair · Ono Pharmaceutical Co. Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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