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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (299)
Facility
City
Region
Status
Research Site
Birmingham
Alabama
Recruiting
Research Site
Little Rock
Arkansas
Not Yet Recruiting
Research Site
La Jolla
California
Not Yet Recruiting
Research Site
Washington D.C.
District of Columbia
Recruiting
Research Site
Fort Lauderdale
Florida
Not Yet Recruiting
Research Site
Gainesville
Florida
Recruiting
Research Site
Jupiter
Florida
Recruiting
Research Site
Miami
Florida
Recruiting
Research Site
Weston
Florida
Not Yet Recruiting
Research Site
Chicago
Illinois
Not Yet Recruiting
Research Site
Evanston
Illinois
Not Yet Recruiting
Research Site
Peoria
Illinois
Recruiting
Research Site
Urbana
Illinois
Recruiting
Research Site
Fort Wayne
Indiana
Recruiting
Research Site
Indianapolis
Indiana
Recruiting
Research Site
Louisville
Kentucky
Recruiting
Research Site
Towson
Maryland
Recruiting
Research Site
Burlington
Massachusetts
Recruiting
Research Site
Worcester
Massachusetts
Not Yet Recruiting
Research Site
Minneapolis
Minnesota
Recruiting
Research Site
Springfield
Missouri
Recruiting
Research Site
Billings
Montana
Recruiting
Research Site
Omaha
Nebraska
Recruiting
Research Site
Las Vegas
Nevada
Recruiting
Research Site
Lebanon
New Hampshire
Not Yet Recruiting
Research Site
Camden
New Jersey
Not Yet Recruiting
Research Site
The Bronx
New York
Not Yet Recruiting
Research Site
Chapel Hill
North Carolina
Recruiting
Research Site
Blue Ash
Ohio
Recruiting
Research Site
Dayton
Ohio
Recruiting
Research Site
Sylvania
Ohio
Not Yet Recruiting
Research Site
Portland
Oregon
Recruiting
Research Site
York
Pennsylvania
Not Yet Recruiting
Research Site
Germantown
Tennessee
Recruiting
Research Site
San Antonio
Texas
Recruiting
Research Site
Tyler
Texas
Recruiting
Research Site
Salt Lake City
Utah
Withdrawn
Research Site
Fairfax
Virginia
Recruiting
Research Site
Roanoke
Virginia
Recruiting
Research Site
Seattle
Washington
Recruiting
+ 259 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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