Recruiting

Phase 3

AZD5335 vs. Standard CareAZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

Sponsor:

AstraZeneca

Code:

NCT07218809

Conditions

Epithelial Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD5335

Mirvetuximab Soravtansine (MIRV)

Paclitaxel

Pegylated liposomal Doxorubicin (PLD)

Topotecan

Study Details

Brief 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.

Conditions

Epithelial Ovarian Cancer

Study ID

NCT07218809

Start date

Dec 29, 2025

Status verified date

Jul, 2026

Completion date

Dec 27, 2029

Anticipated

Primary completion date

Nov 17, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

AZD5335

antibody drug conjugate

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

Paclitaxel

chemotherapy

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

Topotecan

chemotherapy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Birmingham, Alabama, United States, 35223

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20010

Research Site

Recruiting

Gainesville, Florida, United States, 32608

Research Site

Recruiting

Jupiter, Florida, United States, 33458

Research Site

Recruiting

Miami, Florida, United States, 33176

Research Site

Recruiting

Peoria, Illinois, United States, 61637

Research Site

Recruiting

Urbana, Illinois, United States, 61801

Research Site

Recruiting

Fort Wayne, Indiana, United States, 46845

Research Site

Recruiting

Indianapolis, Indiana, United States, 46202

Research Site

Recruiting

Louisville, Kentucky, United States, 40241

Research Site

Recruiting

Towson, Maryland, United States, 21204

Research Site

Recruiting

Burlington, Massachusetts, United States, 01805

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55404

Research Site

Recruiting

Springfield, Missouri, United States, 65807

Research Site

Recruiting

Billings, Montana, United States, 59106

Research Site

Recruiting

Omaha, Nebraska, United States, 68114

Research Site

Recruiting

Las Vegas, Nevada, United States, 89106

Research Site

Recruiting

Chapel Hill, North Carolina, United States, 27599

Research Site

Recruiting

Blue Ash, Ohio, United States, 45242

Research Site

Recruiting

Dayton, Ohio, United States, 45459

Research Site

Recruiting

Portland, Oregon, United States, 97213

Research Site

Recruiting

Germantown, Tennessee, United States, 38138

Research Site

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

Tyler, Texas, United States, 75702

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

Research Site

Recruiting

Roanoke, Virginia, United States, 24016

Research Site

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

AstraZeneca

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

Epithelial Ovarian Cancer
Peritoneal Cancer
Follopian Tube Cancer
Platinum Resistant Ovarian Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-21.