ONO-7913 Phase I Study (ONO-7913)

NCT ID: NCT04403308

Last Updated: 2024-05-03

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2022-01-13

Brief Summary

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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

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-7913 as a Single Agent

Group Type EXPERIMENTAL

ONO-7913

Intervention Type BIOLOGICAL

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

Interventions

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ONO-7913

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with multiple cancers
2. Patients with history of serious allergy
Minimum Eligible Age

20 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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Kazuhiro Nakabayashi

Role: STUDY_CHAIR

Ono Pharmaceutical Co. Ltd

Locations

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Local Institution

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-7913-01

Identifier Type: -

Identifier Source: org_study_id

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