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Clinical Trials in the USA / NCT07218809
Recruiting Phase 3

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

NCT07218809 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-12-29
Last updated
2026-07-21

Condition(s) studied

Epithelial Ovarian Cancer

Investigational drug(s) / intervention(s)

AZD5335Mirvetuximab Soravtansine (MIRV)PaclitaxelPegylated liposomal Doxorubicin (PLD)Topotecan

AZD5335: antibody drug conjugate

Mirvetuximab Soravtansine (MIRV): antibody drug conjugate

Paclitaxel: chemotherapy

Pegylated liposomal Doxorubicin (PLD): chemotherapy

Topotecan: chemotherapy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

Trial sites (299)

FacilityCityRegionStatus
Research Site Birmingham Alabama Recruiting
Research Site Little Rock Arkansas Not Yet Recruiting
Research Site La Jolla California Not Yet Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Fort Lauderdale Florida Not Yet Recruiting
Research Site Gainesville Florida Recruiting
Research Site Jupiter Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Weston Florida Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Evanston Illinois Not Yet Recruiting
Research Site Peoria Illinois Recruiting
Research Site Urbana Illinois Recruiting
Research Site Fort Wayne Indiana Recruiting
Research Site Indianapolis Indiana Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Towson Maryland Recruiting
Research Site Burlington Massachusetts Recruiting
Research Site Worcester Massachusetts Not Yet Recruiting
Research Site Minneapolis Minnesota Recruiting
Research Site Springfield Missouri Recruiting
Research Site Billings Montana Recruiting
Research Site Omaha Nebraska Recruiting
Research Site Las Vegas Nevada Recruiting
Research Site Lebanon New Hampshire Not Yet Recruiting
Research Site Camden New Jersey Not Yet Recruiting
Research Site The Bronx New York Not Yet Recruiting
Research Site Chapel Hill North Carolina Recruiting
Research Site Blue Ash Ohio Recruiting
Research Site Dayton Ohio Recruiting
Research Site Sylvania Ohio Not Yet Recruiting
Research Site Portland Oregon Recruiting
Research Site York Pennsylvania Not Yet Recruiting
Research Site Germantown Tennessee Recruiting
Research Site San Antonio Texas Recruiting
Research Site Tyler Texas Recruiting
Research Site Salt Lake City Utah Withdrawn
Research Site Fairfax Virginia Recruiting
Research Site Roanoke Virginia Recruiting
Research Site Seattle Washington Recruiting

+ 259 more sites — see the full list on the official registry below.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218809 on ClinicalTrials.gov ↗ ← All trials in the USA