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

NCT ID: NCT06535009

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2025-02-26

Brief Summary

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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

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-7914

Group Type EXPERIMENTAL

ONO-7914

Intervention Type DRUG

Specified dose on specified days

ONO-7914+ONO-4538

Group Type EXPERIMENTAL

ONO-7914

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-7914

Specified dose on specified days

Intervention Type DRUG

ONO-4538

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with severe complication
2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-7914-01

Identifier Type: -

Identifier Source: org_study_id

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