Home
Clinical Trials
AZD5335 vs. Mirvetuximab Sora...

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

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-29

Study Completion Date

2030-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

NCT04209855

Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

COMPLETED PHASE3

Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

NCT03598270

Recurrent Ovarian Carcinoma

COMPLETED PHASE3

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

NCT06682988

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers +2 more

RECRUITING PHASE2

Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

NCT03353831

Recurrent Ovarian Carcinoma

COMPLETED PHASE3

Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

NCT00753545

Ovarian Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD5335 in FRa-high cohort

AZD5335 IV (intravenous) in FRa-high cohort

Group Type EXPERIMENTAL

AZD5335

Intervention Type DRUG

antibody drug conjugate

Mirvetuximab Soravtansine (MIRV) in FRa-high cohort

MIRV AIBW IV in FRa-high cohort

Group Type ACTIVE_COMPARATOR

Mirvetuximab Soravtansine (MIRV)

Intervention Type DRUG

antibody drug conjugate

AZD5335 in FRa-low cohort

AZD5335 IV (intravenous) in FRa-low cohort

Group Type EXPERIMENTAL

AZD5335

Intervention Type DRUG

antibody drug conjugate

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

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

chemotherapy

Pegylated liposomal Doxorubicin (PLD)

Intervention Type DRUG

chemotherapy

Topotecan

Intervention Type DRUG

chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD5335

antibody drug conjugate

Intervention Type DRUG

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

Intervention Type DRUG

Paclitaxel

chemotherapy

Intervention Type DRUG

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

Intervention Type DRUG

Topotecan

chemotherapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Elahere Taxol; Onxol Doxil; Caelyx Hycamtin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.