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

April 15, 2025 updated by: Ono Pharmaceutical Co. Ltd

A 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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan
        • Aichi Cancer Center
    • Chiba
      • Kashiwa-shi, Chiba, Japan
        • National Cancer Center Hospital East
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan
        • Kanagawa Cancer Center
    • Osaka
      • Osaka-shi, Osaka, Japan
        • Osaka International Cancer Institute
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
        • Seirei Hamamatsu General Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • The University of Tokyo Hospital
      • Bunkyo-ku, Tokyo, Japan
        • Juntendo University Hpspital
      • Koto-Ku, Tokyo, Japan
        • The Cancer Institute Hospital of JFCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7475+GnP
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: ONO-7475
Specified dose on specified days
Experimental: ONO-7475＋ONO-4538＋GnP
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
Drug: ONO-7475
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event (AE)
Time Frame: Up to 28 days after the last dose
Up to 28 days after the last dose
Dose-limiting toxicities (DLT)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Pharmacokinetics (Plasma concentration of ONO-7475)
Time Frame: Up to Cycle16
Up to Cycle16
Pharmacokinetics (Plasma concentration of ONO-4538)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Anti-ONO-4538 antibody
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Disease Control Rate (DCR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Progression-Free Survival (PFS)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Duration of Response (DOR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Time to Response (TTR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Best Overall Response (BOR)
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Maximum percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
CEA
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
CA19-9
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7475-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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