First in Human Study of AZD9592 in Solid Tumors

Last updated: June 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Osimertinib

5-Fluorouracil (5-FU)

Leucovorin

Clinical Study ID

NCT05647122
D9350C00001
2022-501570-18-00
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age ≥ 18 years

  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

  • Life expectancy ≥ 12 weeks

  • Measurable disease per RECIST v1.1

  • Adequate organ and marrow function as defined in the protocol

Additional Inclusion Criteria for Module 1:

• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.

Additional Inclusion Criteria for Module 2:

• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.

Additional Inclusion Criteria for Module 3:

• Histologically or cytologically confirmed metastatic CRC.

Exclusion

Key Exclusion Criteria:

  • History of (non-infectious) ILD/pneumonitis that required steroids, has currentILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imagingat screening.

  • Spinal cord compression or a history of leptomeningeal carcinomatosis.

  • Active infection including tuberculosis and HBV, HCV or HIV

  • Brain metastases unless treated (prior treatment required only for Module 1),asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10mg prednisone/day or equivalent for at least 4 weeks prior to start of studytreatment.

  • Participants with cardiac comorbidities as defined in the study protocol

Study Design

Total Participants: 228
Treatment Group(s): 5
Primary Treatment: Osimertinib
Phase: 1
Study Start date:
December 22, 2022
Estimated Completion Date:
January 22, 2026

Connect with a study center

  • Research Site

    Kogarah, 2217
    Australia

    Active - Recruiting

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 1X6
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100142
    China

    Active - Recruiting

  • Research Site

    Chongqing, 400030
    China

    Active - Recruiting

  • Research Site

    Guangzhou, 510100
    China

    Active - Recruiting

  • Research Site

    Harbin, 150049
    China

    Site Not Available

  • Research Site

    Wuhan, 430022
    China

    Active - Recruiting

  • Research Site

    Marseille, 13385
    France

    Site Not Available

  • Research Site

    Rennes, 35000
    France

    Active - Recruiting

  • Research Site

    Villejuif Cedex, 94805
    France

    Active - Recruiting

  • Research Site

    Milano, 20162
    Italy

    Active - Recruiting

  • Research Site

    Orbassano, 10043
    Italy

    Active - Recruiting

  • Research Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Research Site

    Verona, 37134
    Italy

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • Research Site

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Research Site

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 11217
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site

    Irvine, California 92618
    United States

    Active - Recruiting

  • Research Site

    North Haven, Connecticut 06473
    United States

    Active - Recruiting

  • Research Site

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Research Site

    Milford, Massachusetts 01757
    United States

    Active - Recruiting

  • Research Site

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10029
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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