ONO-7913 Phase I Study (ONO-7913)
Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04403308
Collaborator
(none)
7
1
1
17.5
0.4
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
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
:
Jul 28, 2020
Actual Primary Completion Date
:
Jan 13, 2022
Actual Study Completion Date
:
Jan 13, 2022
Arms and Interventions
| 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
Primary Outcome Measures
- Dose-limiting toxicities [28 days]
Number of participants with a DLT
- Adverse events [Up to 24 months]
Assessed by the NCI CTCAE v5.0 criteria
Secondary Outcome Measures
- Concentration vs time of ONO-7913 as single dose [Up to 24 months]
PK profile
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Patients with multiple cancers
-
Patients with history of serious allergy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Chuo-ku | Tokyo | Japan |
Sponsors and Collaborators
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Chair: Kazuhiro Nakabayashi, Ono Pharmaceutical Co. Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT04403308
Other Study ID Numbers:
- ONO-7913-01
First Posted:
May 27, 2020
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No