New hope for ovarian cancer: experimental drug AZD5335 faces off against standard care

NCT ID NCT07218809

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing a new drug called AZD5335 against standard treatments (like chemotherapy or another targeted drug) in about 1,100 women with a tough-to-treat type of ovarian cancer that has stopped responding to platinum-based chemotherapy. The goal is to see if AZD5335 can slow cancer growth better than current options. Participants are grouped by whether their tumors have high or low levels of a protein called FRα.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AZD5335 (an antibody drug conjugate)
What this could lead to: If successful, AZD5335 could offer a new, more effective treatment option for women with platinum-resistant ovarian cancer, potentially slowing disease progression.
What could go wrong: This is a large Phase 3 trial, but the drug is still experimental. It may not prove superior to existing treatments, and side effects from the antibody drug conjugate are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial fallopian tube cancer malignant ovarian serous tumor ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epithelial ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

297 sites in 24 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Birmingham, Alabama, 35223, United States
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Little Rock, Arkansas, 72205, United States
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La Jolla, California, 92037, United States
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Washington D.C., District of Columbia, 20010, United States
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Fort Lauderdale, Florida, 33316, United States
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Gainesville, Florida, 32608, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33176, United States
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Weston, Florida, 33331, United States
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Chicago, Illinois, 60612, United States
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Evanston, Illinois, 60201, United States
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Peoria, Illinois, 61637, United States
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Urbana, Illinois, 61801, United States
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Fort Wayne, Indiana, 46845, United States
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Indianapolis, Indiana, 46202, United States
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Louisville, Kentucky, 40241, United States
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Towson, Maryland, 21204, United States
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Burlington, Massachusetts, 01805, United States
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Worcester, Massachusetts, 01655, United States
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Minneapolis, Minnesota, 55404, United States
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Springfield, Missouri, 65807, United States
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Billings, Montana, 59106, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89106, United States
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Lebanon, New Hampshire, 03756, United States
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Camden, New Jersey, 08103, United States
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The Bronx, New York, 10461, United States
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Chapel Hill, North Carolina, 27599, United States
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Blue Ash, Ohio, 45242, United States
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Dayton, Ohio, 45459, United States
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Sylvania, Ohio, 43560, United States
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Portland, Oregon, 97213, United States
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York, Pennsylvania, 17403, United States
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Germantown, Tennessee, 38138, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Salt Lake City, Utah, 84106, United States
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Fairfax, Virginia, 22031, United States
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Roanoke, Virginia, 24016, United States
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Seattle, Washington, 98104, United States
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Adelaide, 5037, Australia
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Auchenflower, 4066, Australia
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Campbelltown, 2560, Australia
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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Cudgen, 2487, Australia
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Garran, 2605, Australia
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Gosford, 2250, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Melbourne, 3000, Australia
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Richmond, 3121, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Namur, 5000, Belgium
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Barretos, 14784-400, Brazil
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Bela Vista, 1317, Brazil
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Curitiba, 81520-060, Brazil
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Goiânia, 74110-060, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350200, Brazil
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Porto Velho, 76834-899, Brazil
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Rio de Janeiro, 20230-130, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01401-002, Brazil
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São Paulo, 01409-902, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, G1G 5X1, Canada
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Port Montt, 5480000, Chile
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Providencia, 7510032, Chile
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Santiago, 7500587, Chile
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Santiago, 7500653, Chile
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Santiago, 7520426, Chile
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Santiago, 8330032, Chile
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Santiago, 8331143, Chile
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Santiago, 8420383, Chile
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Viña del Mar, 2520000, Chile
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Beijing, 100021, China
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Beijing, 100142, China
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Beijing, 102600, China
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Bengbu, 233004, China
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Changchun, 130012, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Fuzhou, 350011, China
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Guangzhou, 510000, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Hangzhou, 310003, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Jinan, 250012, China
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Jinan, 250117, China
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Lanzhou, 730000, China
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Linyi, 276000, China
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Nanchang, 330029, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shijiazhuang, 050020, China
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Taiyuan, 030000, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Zhanjiang, 524001, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Nový Jičín, 741 01, Czechia
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Olomouc, 77900, Czechia
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Prague, 12808, Czechia
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Prague, 150 06, Czechia
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Prague, 18000, Czechia
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Aalborg, 9000, Denmark
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Aarhus, 8200, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Amiens, 80054, France
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Avignon, 84000, France
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Nîmes, 30029, France
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Paris, 75005, France
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Pau, 64046, France
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Pierre-Bénite, 69310, France
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Plerin SUR MER, 22190, France
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Reims, 51056, France
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Saint-Herblain, 44805, France
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Saint-Priest-en-Jarez, 42271, France
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Toulouse, 31300, France
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Tours, 37044, France
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Detmold, 32756, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40225, Germany
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Essen, 45130, Germany
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Essen, 45147, Germany
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Frankfurt am Main, 60487, Germany
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Hamburg, 20246, Germany
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Hamburg, 22457, Germany
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Hanover, 30625, Germany
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Leipzig, 4103, Germany
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Mannheim, 68167, Germany
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Schwäbisch Hall, 74523, Germany
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Tübingen, 72076, Germany
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Ulm, 89075, Germany
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Wiesbaden, 65199, Germany
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Athens, 11528, Greece
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Athens, 12462, Greece
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Athens, 14564, Greece
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Athens, 15123, Greece
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Kalamata, 24100, Greece
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Pátrai, 26332, Greece
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Rio, 26504, Greece
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Thessaloniki, 55236, Greece
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Bhubaneswar, 751007, India
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Chennai, 600113, India
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Delhi, 110029, India
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Dhanvantari Nagar, 605006, India
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Kolkata, 700017, India
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Nagpur, 440001, India
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Nashik, 422 009, India
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Surat, 395002, India
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Tiruchirappalli, 620008, India
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Cork, T12 DV56, Ireland
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Dublin, 7, Ireland
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Dublin, D08 NHY1, Ireland
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Dublin, DO4YN63, Ireland
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Waterford, X91 ER8E, Ireland
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Afula, 1834111, Israel
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Beersheba, 84101, Israel
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Hadera, 38100, Israel
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Haifa, 3109601, Israel
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Haifa, 34362, Israel
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Holon, 5822012, Israel
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Jerusalem, 00000, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 4428164, Israel
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Nahariya, 22100, Israel
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Ramat Gan, 52621, Israel
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Sofia, 1680, Israel
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Tel Aviv, 64239, Israel
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Brescia, 25123, Italy
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Catania, 95126, Italy
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Florence, 50134, Italy
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Lecco, 23900, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Milan, 20162, Italy
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Naples, 80131, Italy
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Parma, 43126, Italy
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Pisa, 56126, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Torino, 10100, Italy
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Akashi-shi, 673-8558, Japan
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Kashiwa, 227-8577, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Sagamihara-shi, 252-0375, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-0023, Japan
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Shinjuku-ku, 160-8582, Japan
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Shiwa-gun, 028-3694, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Tsu, 514-8507, Japan
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Busan, 49241, South Korea
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Daegu, 42601, South Korea
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Goyang-si, 10408, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 08308, South Korea
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Seoul, 5505, South Korea
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Suwon, 16499, South Korea
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Yangsan, 50612, South Korea
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A Coruña, 15006, Spain
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Badalona, 08916, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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Donostia / San Sebastian, 20014, Spain
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Girona, 17007, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Valencia, 46010, Spain
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Linköping, 581 85, Sweden
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Lund, 22242, Sweden
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Solna, 171 64, Sweden
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Umeå, 90737, Sweden
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Uppsala, 751 85, Sweden
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Basel, 4031, Switzerland
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Münsterlingen, 8596, Switzerland
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Sankt Gallen, 9007, Switzerland
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Thun, 3600, Switzerland
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Zollikerberg, CH-8125, Switzerland
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Zurich, 8091, Switzerland
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Changhua, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11259, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10400, Thailand
Research Site
RECRUITING

Bangkok, 10700, Thailand
Research Site
NOT_YET_RECRUITING

Chiang Mai, 50200, Thailand
Research Site
NOT_YET_RECRUITING

Dusit, 10300, Thailand
Research Site
NOT_YET_RECRUITING

Khon Kaen, 40002, Thailand
Research Site
NOT_YET_RECRUITING

Songkhla, 90110, Thailand
Research Site
RECRUITING

Barrow in Furness, LA14 4LF, United Kingdom
Research Site
NOT_YET_RECRUITING

Birmingham, B152GW, United Kingdom
Research Site
NOT_YET_RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Research Site
NOT_YET_RECRUITING

Canterbury, CT1 3NG, United Kingdom
Research Site
NOT_YET_RECRUITING

Cardiff, CF15 7QZ, United Kingdom
Research Site
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Research Site
RECRUITING

Greater London, SW3 6JJ, United Kingdom
Research Site
RECRUITING

London, EC1A 7BE, United Kingdom
Research Site
NOT_YET_RECRUITING

London, SE1 9RT, United Kingdom
Research Site
RECRUITING

Nottingham, NG5 1PB, United Kingdom
Research Site
RECRUITING

Sutton, SM2 5PT, United Kingdom
Research Site
RECRUITING

Swansea, SA12 7BR, United Kingdom

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