AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Last updated: September 30, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Cancer

Stomach Cancer

Adenocarcinoma

Treatment

Irinotecan

AZD0901

Docetaxel

Clinical Study ID

NCT06346392
D9802C00001
2023-508276-11-00
  • Ages 18-130
  • All Genders

Study Summary

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Capable of giving signed informed consent prior to any study procedure.

  2. Participant must be at least 18 years or the legal age of consent in thejurisdiction in which the study is taking place at the time of signing the ICF.

  3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinomaof gastric, GEJ, or distal esophagus (distal third of the esophagus) and thefollowing requirement:

(a) Participants with positive CLDN18.2 expression from archival tumor collectedwithin past 24 months or from a fresh biopsy.

  1. Disease progression on or after at least one prior line of treatment (LoT) foradvanced or metastatic disease, which included a fluoropyrimidine and a platinum,for advanced or metastatic disease.

  2. Must have at least one measurable or evaluable lesion assessed by the Investigatorbased on RECIST 1.1.

  3. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeksprior to baseline or day of first dosing.

  4. Predicted life expectancy of ≥ 12 weeks.

  5. Adequate organ and bone marrow function

  6. Body weight of ≥ 35 kg.

  7. Sex and Contraceptive Requirements

Exclusion

Exclusion Criteria:

  1. Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cellare considered positive by ISH). Participants must undergo local (or have had) HER2testing by IHC/ISH, and the most recent result of HER2 status will be used todetermine the eligibility.

  2. Participant has significant or unstable gastric bleeding and/or untreated gastriculcers.

  3. CNS metastases or CNS pathology including: epilepsy, seizures or aphasia within 3months prior to consent, severe brain injury, dementia, Parkinson's disease,neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness,psychosis, CNS involvement of autoimmune diseases.

  4. Participant has known clinically significant corneal disease (eg, active keratitisor corneal ulcerations).

  5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy,excluding alopecia. Participants with irreversible toxicity that is not reasonablyexpected to be exacerbated by study intervention may be included (eg, hearing loss).

  6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatmentother than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy,multi-specific antibody including targeting CLDN18.2, etc).

  7. History of thromboembolic events:

  8. Participants with venous thromboembolism within the past 6 months prior torandomization: participants with venous port or catheter thrombosis orsuperficial venous thrombus that do not require treatment or are stable ontreatment with anticoagulants are excepted

  9. History of arterial thromboembolism within the past 12 months prior torandomization

  10. As judged by the Investigator, any evidence of diseases which in the Investigator'sopinion, makes it undesirable for the participant to participate in the study orthat would jeopardize compliance with the protocol.

Study Design

Total Participants: 572
Treatment Group(s): 7
Primary Treatment: Irinotecan
Phase: 3
Study Start date:
March 04, 2024
Estimated Completion Date:
April 19, 2027

Study Description

This is a Phase III, multi-center, open-label, sponsor-blinded, randomized, global study to assess the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as the 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, the efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 assay as an IVD device for the identification of patients with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2 who may benefit from AZD0901.

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    Active - Recruiting

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Research Site

    Irvine, California 92618
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90089
    United States

    Site Not Available

  • Research Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • Research Site

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Research Site

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Research Site

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • Research Site

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • Research Site

    Los Angeles 5368361, California 5332921 90089
    United States

    Active - Recruiting

  • Research Site

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • Research Site

    Santa Rosa 5393287, California 5332921 95403
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Research Site

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Active - Recruiting

  • Research Site

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Research Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Research Site

    Fleming Island 4155594, Florida 4155751 32003
    United States

    Active - Recruiting

  • Research Site

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Research Site

    Orlando 4167147, Florida 4155751 32804
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Research Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Research Site

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • Research Site

    Honolulu, Hawaii 96819
    United States

    Site Not Available

  • Research Site

    Honolulu 5856195, Hawaii 5855797 96819
    United States

    Active - Recruiting

  • Research Site

    Boise, Idaho 83712
    United States

    Site Not Available

  • Research Site

    Boise 5586437, Idaho 5596512 83712
    United States

    Active - Recruiting

  • Research Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Research Site

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Research Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Research Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Research Site

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

  • Research Site

    St Louis 4407066, Missouri 4398678 63128
    United States

    Site Not Available

  • Research Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Research Site

    New York, New York 10032
    United States

    Site Not Available

  • Research Site

    Mineola 5127134, New York 5128638 11501
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Research Site

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Research Site

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Active - Recruiting

  • Research Site

    York 4562407, Pennsylvania 6254927 17403
    United States

    Active - Recruiting

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Research Site

    Fredericksburg, Virginia 22408
    United States

    Site Not Available

  • Research Site

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Active - Recruiting

  • Research Site

    Fredericksburg 4760059, Virginia 6254928 22408
    United States

    Active - Recruiting

  • Research Site

    Olympia, Washington 98502
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98109
    United States

    Site Not Available

  • Research Site

    Olympia 5805687, Washington 5815135 98502
    United States

    Active - Recruiting

  • Research Site

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh city, 700000
    Vietnam

    Site Not Available

  • Research Site

    Vinh, 460000
    Vietnam

    Site Not Available

  • Research Site

    Vinh 1562798, 460000
    Vietnam

    Active - Recruiting

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