NCT04403308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 21, 2020

Last Update Submit

May 2, 2024

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities

    Number of participants with a DLT

    28 days

  • Adverse events

    Assessed by the NCI CTCAE v5.0 criteria

    Up to 24 months

Secondary Outcomes (1)

  • Concentration vs time of ONO-7913 as single dose

    Up to 24 months

Study Arms (1)

ONO-7913 as a Single Agent

EXPERIMENTAL
Biological: ONO-7913

Interventions

ONO-7913BIOLOGICAL

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

ONO-7913 as a Single Agent

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with multiple cancers
  • Patients with history of serious allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Chuo-ku, Tokyo, Japan

Location

Study Officials

  • Kazuhiro Nakabayashi

    Ono Pharmaceutical Co. Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

July 28, 2020

Primary Completion

January 13, 2022

Study Completion

January 13, 2022

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)