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AZD5335 for Platinum-Resistant Ovarian Cancer

This study is testing a new drug, AZD5335, for women with high-grade, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Platinum-resistant means the cancer has grown or returned after platinum-based chemotherapy. Researchers want to see if AZD5335 works better than standard treatments like Mirvetuximab Soravtansine or chemotherapy (Paclitaxel, Pegylated liposomal Doxorubicin, or Topotecan). The study will look at how long people live without their cancer getting worse (progression-free survival). You would need to be at least 18 years old and have a confirmed diagnosis of one of these cancers. The study is currently recruiting about 1100 participants.

Study design
This is an interventional study with approximately 1100 adult participants. Participants will be assigned by chance (randomized) to receive either AZD5335 or a standard treatment.
What's involved
Participants will remain on their assigned treatment and have regular tumor evaluations until their disease progresses or they need to stop treatment for another reason.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed for overall survival, and progression-free survival will be measured for up to approximately 5 years.

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NCT07218809

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~1,100 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:AZD5335Mirvetuximab Soravtansine (MIRV)PaclitaxelPegylated liposomal Doxorubicin (PLD)Topotecan

At a glance

Recruiting sites
95 of 299 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free Survival (PFS)
Measured over Up to approximately 5 years

Conditions

Epithelial Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaOvarian CarcinomaPrimary Peritoneal CancerFRα

Where it's being run

299 sites across 53 states
China39
Japan20
Germany17
Australia14
Brazil14
Italy14
Israel13
France12

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression free Survival (PFS)Up to approximately 5 years

    PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.