ONO-7913 Phase I Study (ONO-7913) | NCT04403308

Studies
ONO-7913 Phase I Study (ONO-7913)

NCT04403308

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

May 3, 2024Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

ONO-7913

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Jan 13, 2022Actual

Completion Date

Jan 13, 2022Actual

First Submitted Date

May 21, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2024

Last Update Posted Date

May 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONO-7913 as a Single Agent	Experimental		Biological: ONO-7913

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-7913	Biological	ONO-7913 will be administered by intravenous continuous infusion during the designated time.	ONO-7913 as a Single Agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Concentration vs time of ONO-7913 as single dose	PK profile	Up to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kazuhiro Nakabayashi	Ono Pharmaceutical Co., Ltd.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Chuo-ku	Tokyo		Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41888930	Derived	Koyama T, Shimizu T, Kondo S, Katsuya Y, Sudo K, Yoshida T, Yonemori K, Matsumoto K, Yamamoto N. Tolerability and safety of magrolimab (ONO-7913) in Japanese patients with advanced or metastatic solid tumors: a phase 1, open-label, uncontrolled, dose-escalation study. BMC Res Notes. 2026 Mar 26;19(1):203. doi: 10.1186/s13104-026-07787-6.