Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07044336
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Puxitatug Samrotecan — DRUG
    2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
  • Doxorubicin — DRUG
    60 mg/m2 on Day 1 Q3W Route of administration: IV
  • Paclitaxel — DRUG
    80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV

Study Details

This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.

Key Dates

Start date
Aug 1, 2025
Status verified
May 2026
Primary completion
Oct 15, 2027
Completion
Jul 17, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Puxitatug Samrotecan
    Puxi-Sam IV (intravenous) Q3W .
  • Active Comparator: Chemotherapy
    Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.

Primary Outcome Measure

Progression Free Survival (PFS) for Arm A vs Arm B [ Time Frame: Approximately 3 years ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteLa JollaCalifornia92037-
Research SiteLos AngelesCalifornia90095-
Research SiteOrangeCalifornia92868-
Research SiteWashington D.C.District of Columbia20016-
Research SiteJupiterFlorida33458-
Research SiteMiamiFlorida33136-
Research SiteMiamiFlorida33176-
Research SiteMiami BeachFlorida33140-
Research SiteNew Port RicheyFlorida34655-
Research SiteOrlandoFlorida32806-
Research SiteTampaFlorida33612-
Research SiteWest Palm BeachFlorida33401-
Research SiteHonoluluHawaii96826-
Research SiteChicagoIllinois60607-
Research SitePeoriaIllinois61637-
Research SiteUrbanaIllinois61801-
Research SiteFort WayneIndiana46845-
Research SiteIndianapolisIndiana46260-
Research SiteScarboroughMaine04074-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21231-
Research SiteSilver SpringMaryland20910-
Research SiteAnn ArborMichigan48109-
Research SiteAnn ArborMichigan48197-
Research SiteDetroitMichigan48201-
Research SiteMinneapolisMinnesota55404-
Research SiteCamdenNew Jersey08103-
Research SiteParamusNew Jersey07652-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteBrooklynNew York11220-
Research SiteStony BrookNew York11794-
Research SiteThe BronxNew York10461-
Research SiteWhite PlainsNew York10601-
Research SiteGreenvilleNorth Carolina27834-
Research SitePinehurstNorth Carolina28374-
Research SiteCincinnatiOhio45220-
Research SiteClevelandOhio44106-
Research SiteClevelandOhio44109-
Research SiteColumbusOhio43219-
Research SiteDaytonOhio45459-
Research SiteHilliardOhio43026-
Research SiteSylvaniaOhio43560-
Research SiteEugeneOregon97401-
Research SitePortlandOregon97239-
Research SiteBethlehemPennsylvania18015-
Research SiteHersheyPennsylvania17033-
Research SiteLancasterPennsylvania17601-
Research SitePittsburghPennsylvania15213-
Research SitePittsburghPennsylvania15224-
Research SiteWillow GrovePennsylvania19090-
Research SiteYorkPennsylvania17403-
Research SiteSioux FallsSouth Dakota57104-
Research SiteSioux FallsSouth Dakota57105-
Research SiteKnoxvilleTennessee37920-
Research SiteNashvilleTennessee37232-
Research SiteAustinTexas78758-
Research SiteHoustonTexas77030-
Research SiteTylerTexas75702-
Research SiteFairfaxVirginia22031-
Research SiteFalls ChurchVirginia22042-
Research SiteNorfolkVirginia23502-
Research SiteRichmondVirginia23298-
Research SiteRoanokeVirginia24016-
Research SiteKennewickWashington99336-
Research SiteSeattleWashington98104-
Research SiteMorgantownWest Virginia26505-
Research SiteWaukeshaWisconsin53188-

Find similar trials in Tucson, AZ

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Research Site· Tucson, AZResearch Site· La Jolla, CAResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· Washington D.C., DCResearch Site· Jupiter, FL

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