AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07218809
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • AZD5335 — DRUG
    antibody drug conjugate
  • Mirvetuximab Soravtansine (MIRV) — DRUG
    antibody drug conjugate
  • Paclitaxel — DRUG
    chemotherapy
  • Pegylated liposomal Doxorubicin (PLD) — DRUG
    chemotherapy
  • Topotecan — DRUG
    chemotherapy

Study Details

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Key Dates

First listed
Oct 20, 2025
Start date
Dec 29, 2025
Status verified
Jul 2026
Primary completion
Nov 17, 2028
Completion
Dec 27, 2029

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD5335 in FRa-high cohort
    AZD5335 IV (intravenous) in FRa-high cohort
  • Active Comparator: Mirvetuximab Soravtansine (MIRV) in FRa-high cohort
    MIRV AIBW IV in FRa-high cohort
  • Experimental: AZD5335 in FRa-low cohort
    AZD5335 IV (intravenous) in FRa-low cohort
  • Active Comparator: Investigator´s choice chemotherapy in FRa-low cohort
    Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor

Primary Outcome Measure

Progression free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35223-
Research SiteLittle RockArkansas72205-
Research SiteLa JollaCalifornia92037-
Research SiteWashington D.C.District of Columbia20010-
Research SiteFort LauderdaleFlorida33316-
Research SiteGainesvilleFlorida32608-
Research SiteJupiterFlorida33458-
Research SiteMiamiFlorida33176-
Research SiteWestonFlorida33331-
Research SiteChicagoIllinois60612-
Research SiteEvanstonIllinois60201-
Research SitePeoriaIllinois61637-
Research SiteUrbanaIllinois61801-
Research SiteFort WayneIndiana46845-
Research SiteIndianapolisIndiana46202-
Research SiteLouisvilleKentucky40241-
Research SiteTowsonMaryland21204-
Research SiteBurlingtonMassachusetts01805-
Research SiteWorcesterMassachusetts01655-
Research SiteMinneapolisMinnesota55404-
Research SiteSpringfieldMissouri65807-
Research SiteBillingsMontana59106-
Research SiteOmahaNebraska68114-
Research SiteLas VegasNevada89106-
Research SiteLebanonNew Hampshire03756-
Research SiteCamdenNew Jersey08103-
Research SiteThe BronxNew York10461-
Research SiteChapel HillNorth Carolina27599-
Research SiteBlue AshOhio45242-
Research SiteDaytonOhio45459-
Research SiteSylvaniaOhio43560-
Research SitePortlandOregon97213-
Research SiteYorkPennsylvania17403-
Research SiteGermantownTennessee38138-
Research SiteSan AntonioTexas78229-
Research SiteTylerTexas75702-
Research SiteSalt Lake CityUtah84106-
Research SiteFairfaxVirginia22031-
Research SiteRoanokeVirginia24016-
Research SiteSeattleWashington98104-

Find similar trials in Birmingham, AL

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials
By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health

Related Studies