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NCT07218809Recruiting

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

Official recordSimplified version

Summary

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.

Inclusion criteria

• Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer. • Participants must have platinum-resistant disease: • Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum. • Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum. • Participants must have radiologically progressed on or after their most recent line of therapy. • Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment • Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance. • Provision of an FFPE tumour tissue sample

Exclusion criteria

• Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour. • Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy. • Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring • Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease. • Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. • Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC. • Major surgical procedure within 4 weeks of the first dose of study intervention

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, United States, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Greece, India, Ireland, Israel, Japan, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom
Sponsor
AstraZeneca(Industry)
Protocol no.
D8991C00001
Conditions
Epithelial Ovarian Cancer
Interventions
Drug

Treatments studied

  • AZD5335
  • Mirvetuximab Soravtansine (MIRV)
  • Paclitaxel
  • Pegylated liposomal Doxorubicin (PLD)
  • Topotecan

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Ventana Medical Systems, Inc

Locations · 95

  • Avignon, FranceResearch SiteRecruiting at this site
  • Paris, FranceResearch SiteRecruiting at this site
  • Pau, FranceResearch SiteRecruiting at this site
  • Pierre-Bénite, FranceResearch SiteRecruiting at this site
  • Saint-Herblain, FranceResearch SiteRecruiting at this site
  • Saint-Priest-en-Jarez, FranceResearch SiteRecruiting at this site
  • Tours, FranceResearch SiteRecruiting at this site
  • Birmingham, United StatesResearch SiteRecruiting at this site
  • Washington D.C., United StatesResearch SiteRecruiting at this site
  • Gainesville, United StatesResearch SiteRecruiting at this site
  • Jupiter, United StatesResearch SiteRecruiting at this site
  • Miami, United StatesResearch SiteRecruiting at this site
  • Peoria, United StatesResearch SiteRecruiting at this site
  • Urbana, United StatesResearch SiteRecruiting at this site
  • Fort Wayne, United StatesResearch SiteRecruiting at this site
  • Indianapolis, United StatesResearch SiteRecruiting at this site
  • Louisville, United StatesResearch SiteRecruiting at this site
  • Towson, United StatesResearch SiteRecruiting at this site
  • Burlington, United StatesResearch SiteRecruiting at this site
  • Minneapolis, United StatesResearch SiteRecruiting at this site
  • Springfield, United StatesResearch SiteRecruiting at this site
  • Billings, United StatesResearch SiteRecruiting at this site
  • Omaha, United StatesResearch SiteRecruiting at this site
  • Las Vegas, United StatesResearch SiteRecruiting at this site
  • Chapel Hill, United StatesResearch SiteRecruiting at this site
  • Blue Ash, United StatesResearch SiteRecruiting at this site
  • Dayton, United StatesResearch SiteRecruiting at this site
  • Portland, United StatesResearch SiteRecruiting at this site
  • Germantown, United StatesResearch SiteRecruiting at this site
  • San Antonio, United StatesResearch SiteRecruiting at this site

In total, worldwide, 95 of the 299 sites listed in the registry are recruiting; the other 204 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 21, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 65 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.