Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07431281
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Key Dates

Start date
Feb 3, 2026
Status verified
May 2026
Primary completion
Aug 16, 2029
Completion
Oct 27, 2031

Study Design

Enrollment
2,130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Sonesitatug vedotin + Rilvegostomig + Capecitabine
  • Experimental: Arm B
    Sonesitatug vedotin + Nivolumab + Capecitabine
  • Active Comparator: Arm C
    Nivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin
  • Experimental: Arm D
    Sonesitatug vedotin + Capecitabine
  • Active Comparator: Arm E
    Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin

Primary Outcome Measure

Progression Free Survival (PFS) (Cohort 1 and Cohort 2) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (77)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteSpringdaleArkansas72762-
Research SiteDuarteCalifornia91010-
Research SiteFullertonCalifornia92835-
Research SiteLa JollaCalifornia92093-
Research SiteLos AlamitosCalifornia90720-
Research SiteOrangeCalifornia92868-
Research SiteWalnut CreekCalifornia94598-
Research SiteDenverColorado80210-
Research SiteLone TreeColorado80124-
Research SiteNew HavenConnecticut06510-
Research SiteNewarkDelaware19713-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort MyersFlorida33901-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32806-
Research SiteSt. PetersburgFlorida33705-
Research SiteWest Palm BeachFlorida33401-
Research SiteAtlantaGeorgia30309-
Research SiteAtlantaGeorgia30322-
Research SiteAtlantaGeorgia30342-
Research SiteMaconGeorgia31201-
Research SiteNewnanGeorgia30265-
Research SiteChicagoIllinois60637-
Research SiteNilesIllinois60714-
Research SiteZionIllinois60099-
Research SiteIndianapolisIndiana46260-
Research SiteWaukeeIowa50263-
Research SiteLexingtonKentucky40536-
Research SiteLouisvilleKentucky40217-
Research SiteBostonMassachusetts02114-
Research SiteBurlingtonMassachusetts01803-
Research SiteGrand RapidsMichigan49503-
Research SiteBurnsvilleMinnesota55337-
Research SiteDuluthMinnesota55805-
Research SiteRochesterMinnesota55905-
Research SiteKansas CityMissouri64132-
Research SiteSt LouisMissouri63110-
Research SiteCamdenNew Jersey08103-
Research SiteEast BrunswickNew Jersey08816-
Research SiteHackensackNew Jersey07601-
Research SiteNew BrunswickNew Jersey08901-
Research SiteSummitNew Jersey07901-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SiteThe BronxNew York10461-
Research SiteThe BronxNew York10468-
Research SiteWhite PlainsNew York10601-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43221-
Research SitePortlandOregon97213-
Research SitePortlandOregon97239-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15232-
Research SitePittsburghPennsylvania15240-
Research SiteWilkes-BarrePennsylvania18711-
Research SiteYorkPennsylvania17403-
Research SiteCharlestonSouth Carolina29425-
Research SiteSioux FallsSouth Dakota57105-
Research SiteMemphisTennessee38104-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75235-
Research SiteDallasTexas75246-
Research SiteShermanTexas75090-
Research SiteBlacksburgVirginia24060-
Research SiteFairfaxVirginia22031-
Research SiteFalls ChurchVirginia22042-
Research SiteFort BelvoirVirginia22060-
Research SiteRichmondVirginia23219-
Research SiteOlympiaWashington98502-
Research SiteSeattleWashington98104-
Research SiteCharlestonWest Virginia25315-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Research Site· Phoenix, AZResearch Site· Springdale, ARResearch Site· Duarte, CAResearch Site· Fullerton, CAResearch Site· La Jolla, CAResearch Site· Los Alamitos, CA

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