Study Comparing AZD5335 with Other Treatments for Platinum-resistant Ovarian Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07218809
This clinical trial is testing whether the new drug AZD5335 is more effective than current treatments for women with high-grade ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum-based chemotherapy. The study focuses on patients with different levels of a protein called FRα.
Patient Parameters
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Program Overview
The study aims to find out if AZD5335 can help women with certain types of ovarian cancer live longer without their cancer getting worse. It compares AZD5335 to standard treatments in women whose cancer has high or low levels of a protein called FRα. The trial will include about 1100 women, divided into two groups based on their FRα levels. Each group will receive either AZD5335 or the standard treatment for their FRα level. Participants will continue their assigned treatment and have regular check-ups to monitor their cancer until it progresses or they need to stop for another reason. The study will also track overall survival rates, and an independent committee will regularly review the safety and effectiveness of the treatments.
Description
In this study, around 1100 women with high-grade ovarian, fallopian tube, or primary peritoneal cancer that does not respond to platinum-based chemotherapy will participate. They will be divided into two groups based on the levels of a protein called FRα in their cancer cells. One group will have high FRα levels, and the other will have low FRα levels. Each group will be randomly assigned to receive either the new drug AZD5335 or the standard treatment for their FRα level. For those with high FRα, the standard treatment is a drug called mirvetuximab soravtansine. For those with low FRα, the standard treatment is a chemotherapy chosen by their doctor. Participants will stay on their assigned treatment and have regular scans to check their cancer until it gets worse or they need to stop for another reason. The study will also follow all participants to see how long they live overall. An independent group of experts will regularly check the safety and progress of the study to ensure it is conducted properly.
Eligibility 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33316 | Fort Lauderdale | Florida |
| Research Site | 33458 | Jupiter | Florida |
| Research Site | 60201 | Evanston | Illinois |
| Research Site | 61637 | Peoria | Illinois |
| Research Site | 61801 | Urbana | Illinois |
| Research Site | 21204 | Towson | Maryland |
| Research Site | 01805 | Burlington | Massachusetts |
| Research Site | 01655 | Worcester | Massachusetts |
| Research Site | 55404 | Minneapolis | Minnesota |
| Research Site | 68114 | Omaha | Nebraska |
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