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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT07218809

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD5335 (drug), Mirvetuximab Soravtansine (MIRV) (drug), Paclitaxel (drug), Pegylated liposomal Doxorubicin (PLD) (drug)
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
AZD5335 — drug: antibody drug conjugate · Mirvetuximab Soravtansine (MIRV) — drug: antibody drug conjugate · Paclitaxel — drug: chemotherapy · Pegylated liposomal Doxorubicin (PLD) — drug: chemotherapy · Topotecan — drug: chemotherapy
Patient visit burden
Not specified by the sponsor

In plain English

This AstraZeneca study looks at a drug called AZD5335 in people with epithelial ovarian cancer that has stopped responding to platinum chemotherapy. In people whose cancer has high levels of a protein called FRα, AZD5335 is compared with mirvetuximab soravtansine. In people whose cancer has low FRα levels, AZD5335 is compared with chemotherapy.

Who can take part

  • Confirmed diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Cancer is resistant to platinum chemotherapy (for example, the cancer came back or got worse within 6 months of the last platinum dose, with extra rules if you had only one course)
  • Cancer has got worse on or after your most recent treatment, shown on a scan
  • You have had at least 1 but no more than 3 previous courses of anti-cancer treatment, and single-drug treatment is suitable as your next option
  • If you have a BRCA gene change, you must have already had a PARP inhibitor (a type of targeted drug) if you were suitable for it, unless there was a medical reason not to
  • You can provide a stored tumour tissue sample

Who may not be able to

  • Certain cancer types: endometrioid, clear cell, mucinous or sarcomatous; mixed tumours containing these; or low-grade or borderline ovarian tumours
  • Cancer that never responded to the first platinum chemotherapy or got worse within 3 months of it
  • Active or long-term cornea (front of the eye) problems, past cornea transplant, or eye conditions needing ongoing treatment or monitoring
  • Current signs or tests suggesting a blocked bowel
  • Non-infectious lung inflammation (ILD/pneumonitis), now or in the past needing steroid tablets or injections or extra oxygen, or if it cannot be ruled out on a scan
  • Previous treatment targeting FRα, including mirvetuximab soravtansine, or any drug that delivers a TOP1 inhibitor (a chemotherapy-type drug) attached to an antibody
  • Major surgery within 4 weeks of the first study dose

What taking part involves

  • • Taking the study drug AZD5335, or the comparison treatment (mirvetuximab soravtansine or chemotherapy, depending on your FRα level) — details of how the drugs are given are not stated; ask the trial team

Time commitment: Not stated — ask the trial team about number of visits, how long the trial lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
1,100
Started
2025-12-29
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for epithelial ovarian cancer
  • • Phase3 - 1,100 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with epithelial ovarian cancer
  • • Female only

Where?

  • • Barrow in Furness - Research Site
  • • Birmingham - Research Site
  • • Cambridge - Research Site
  • • Canterbury - Research Site
  • • +8 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation. All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.

Epithelial Ovarian Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

PR

Treatment history

Treatments you must have had:

  • ✓ platinum-resistant disease:
  • ✓ of platinum-based therapy must have received at least 4 cycles of platinum
  • ✓ progressed ≤ 6 months after the date of the last dose of platinum
  • ✓ radiologically progressed on or after their most recent line of therapy

What the study is looking for

  • ✓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 received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of...
  • ✓Participants must have radiologically progressed on or after their most recent line of therapy.
See the full criteria
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

Where Is This Study? (12 UK sites)

Research Site

Barrow in Furness LA14 4LF, United Kingdom

Recruiting

Research Site

Birmingham B152GW, United Kingdom

NOT_YET_RECRUITING

Research Site

Cambridge CB2 0QQ, United Kingdom

NOT_YET_RECRUITING

Research Site

Canterbury CT1 3NG, United Kingdom

NOT_YET_RECRUITING

Research Site

Cardiff CF15 7QZ, United Kingdom

NOT_YET_RECRUITING

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

Greater London SW3 6JJ, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

London SE1 9RT, United Kingdom

NOT_YET_RECRUITING

Research Site

Nottingham NG5 1PB, United Kingdom

Recruiting

Research Site

Sutton SM2 5PT, United Kingdom

Recruiting

Research Site

Swansea SA12 7BR, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07