A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer

NCT ID: NCT06532331

Last Updated: 2025-04-18

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2028-03-31

Brief Summary

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This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment

Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-7475+GnP

Group Type EXPERIMENTAL

ONO-7475

Intervention Type DRUG

Specified dose on specified days

Nab-paclitaxel

Intervention Type DRUG

Specified dose on specified days

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

ONO-7475+ONO-4538+GnP

Group Type EXPERIMENTAL

ONO-7475

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Nab-paclitaxel

Intervention Type DRUG

Specified dose on specified days

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-7475

Specified dose on specified days

Intervention Type DRUG

ONO-4538

Specified dose on specified days

Intervention Type DRUG

Nab-paclitaxel

Specified dose on specified days

Intervention Type DRUG

Gemcitabine

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Nivolumab

Eligibility Criteria

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Inclusion Criteria

1. Patient with metastatic pancreatic cancer
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 6 months

Exclusion Criteria

1. Patients are unable to swallow oral medications
2. Patients with severe complication
Minimum Eligible Age

18 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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Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Juntendo University Hpspital

Bunkyo-ku, Tokyo, Japan

Site Status

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

The Cancer Institute Hospital Of JFCR

Koto-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-7475-04

Identifier Type: -

Identifier Source: org_study_id

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