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

Last updated: April 15, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Not Recruiting

Phase

1

Condition

Digestive System Neoplasms

Metastatic Cancer

Treatment

ONO-4538

Nab-paclitaxel

Gemcitabine

Clinical Study ID

NCT06532331
ONO-7475-04
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients are unable to swallow oral medications

  2. Patients with severe complication

Study Design

Total Participants: 87
Treatment Group(s): 4
Primary Treatment: ONO-4538
Phase: 1
Study Start date:
December 06, 2023
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • Aichi Cancer Center

    Nagoya-shi, Aichi
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa-shi, Ishikawa
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama-shi, Kanagawa
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka-shi, Osaka
    Japan

    Site Not Available

  • Seirei Hamamatsu General Hospital

    Hamamatsu-shi, Shizuoka
    Japan

    Site Not Available

  • Juntendo University Hpspital

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • The Cancer Institute Hospital Of JFCR

    Koto-Ku, Tokyo
    Japan

    Site Not Available

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