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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06346392
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0901 — DRUG
    Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
  • AZD0901 — DRUG
    Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
  • Ramucirumab+ paclitaxel — DRUG
    Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
  • Docetaxel — DRUG
    Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
  • Irinotecan — DRUG
    Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
  • TAS-102 — DRUG
    TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)
  • Apatinib — DRUG
    Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)

Study Details

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.

Key Dates

Start date
Mar 4, 2024
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Oct 14, 2026

Study Design

Enrollment
592 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0901 arm 1
    Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
  • Experimental: AZD0901 Arm 2
    Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)
  • Active Comparator: Investigator's choice arm
    Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.

Primary Outcome Measure

Progression Free Survival (PFS) in all randomized participants [ Time Frame: From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years). ]

Locations (26)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36604-
Research SiteTucsonArizona85719-
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteLos AngelesCalifornia90048-
Research SiteLos AngelesCalifornia90089-
Research SiteNewport BeachCalifornia92663-
Research SiteWashington D.C.District of Columbia20007-
Research SiteHollywoodFlorida33021-
Research SiteOrlandoFlorida32804-
Research SiteMariettaGeorgia30060-
Research SiteBoiseIdaho83712-
Research SiteLexingtonKentucky40536-
Research SiteBostonMassachusetts02114-
Research SiteAnn ArborMichigan48106-
Research SiteAnn ArborMichigan48109-
Research SiteKansas CityMissouri64111-
Research SiteMineolaNew York11501-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SitePhiladelphiaPennsylvania19111-
Research SiteYorkPennsylvania17403-
Research SiteCharlottesvilleVirginia22908-
Research SiteFredericksburgVirginia22408-
Research SiteOlympiaWashington98502-

Find similar trials in Mobile, AL

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Research Site· Mobile, ALResearch Site· Tucson, AZResearch Site· Duarte, CAResearch Site· Irvine, CAResearch Site· Los Angeles, CAResearch Site· Newport Beach, CA

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