Study of ONO-7914 Alone and in Combination With ONO-4538... | NCT06535009

Studies
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

NCT06535009

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Terminated

Last Update Posted

Jun 4, 2025Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

ONO-7914
ONO-4538

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 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to strategic reasons

Expanded Access Info

Start Date

Feb 8, 2022Actual

Primary Completion Date

Feb 26, 2025Actual

Completion Date

Feb 26, 2025Actual

First Submitted Date

Jul 21, 2024

First Submission Date that Met QC Criteria

Jul 30, 2024

First Posted Date

Aug 2, 2024Actual

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

Jun 1, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONO-7914	Experimental		Drug: ONO-7914
ONO-7914+ONO-4538	Experimental		Drug: ONO-7914 Drug: ONO-4538

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-7914	Drug	Specified dose on specified days	ONO-7914 ONO-7914+ONO-4538

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Limiting Toxicity		28 days
Adverse Events as assessed by CTCAE v5.0		Up to 28 days after the completion of treatment period

Secondary Outcomes

Measure	Description	Time Frame
Plasma concentration of ONO-7914		Up to 21 days after the first treatment
Urine concentration of ONO-7914		Up to 24 hours after the first treatment
Serum concentration of ONO-4538

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with advanced or metastatic solid tumor
Patients with ECOG performance status of 0 or 1
Patients with a life expectancy of at least 3 months

Exclusion Criteria:

Patients with severe complication
Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Project Leader	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Institute Hospital of JFCR		Koto-ku	Tokyo		Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077594	Nivolumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

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Browse Branches

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