AZD5335 for Platinum-Resistant Ovarian Cancer
(TREVI-OC-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, AZD5335, for women with a specific type of ovarian cancer that does not respond well to platinum-based treatments. The researchers aim to determine if AZD5335 can help these patients live longer without their cancer worsening compared to standard treatments. The trial involves different groups based on the levels of a protein called FRα, which may be present in cancer cells. Women with high-grade ovarian, fallopian tube, or primary peritoneal cancer who have experienced progression after platinum treatments might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found AZD5335 to be safe for patients with platinum-resistant ovarian cancer. While some side effects occurred, they were mostly mild and manageable by doctors. Early research suggests AZD5335 may be effective against this cancer type.
Research also shows that Mirvetuximab Soravtansine is generally well-tolerated by patients with FRα-positive, platinum-resistant ovarian cancer. Studies have demonstrated significant benefits over traditional chemotherapy, with fewer severe side effects.
For those considering joining this clinical trial, these findings indicate that both AZD5335 and Mirvetuximab Soravtansine have undergone safety studies in humans, with usually manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD5335 because it offers a novel approach for treating platinum-resistant ovarian cancer. Unlike standard treatments such as paclitaxel, pegylated liposomal doxorubicin, or topotecan, which rely on traditional chemotherapy mechanisms, AZD5335 targets specific genetic markers in cancer cells, potentially improving effectiveness and reducing side effects. Additionally, AZD5335 is administered intravenously and designed to work well in patients with both FRa-high and FRa-low tumors, offering a more personalized treatment option. This targeted therapy could change the game by providing a more precise attack on cancer cells, leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for platinum-resistant ovarian cancer?
Research has shown that AZD5335, one of the treatments in this trial, could be promising for treating ovarian cancer. It targets a protein called FRα on cancer cells and delivers a potent cancer-fighting drug directly to them. In studies with cancer models similar to human cases, AZD5335 had a response rate of 82%, indicating it might effectively slow or stop cancer growth.
Mirvetuximab Soravtansine, another treatment option in this trial, has demonstrated superior efficacy compared to traditional chemotherapy for patients with FRα-positive, platinum-resistant ovarian cancer. It helps patients live longer without cancer progression and also increases overall survival time. These findings suggest that both treatments could be beneficial for managing difficult-to-treat ovarian cancer.12567Are You a Good Fit for This Trial?
This trial is for women with high-grade, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. They must have had a limited number of prior treatments and shown progression after their most recent therapy. Participants need to provide a tumor tissue sample and those with BRCA mutations should have tried PARPi unless contraindicated.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD5335 or standard of care (mirvetuximab soravtansine or investigator's choice chemotherapy) until disease progression or treatment discontinuation
Follow-up
Participants are monitored for overall survival and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- AZD5335
- Mirvetuximab Soravtansine
Trial Overview
The study tests AZD5335 against standard chemotherapy drugs (Paclitaxel, PLD, Topotecan) or MIRV in patients with different levels of FRα expression. The goal is to see if AZD5335 can extend the time without disease progression better than current treatments.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
AZD5335 IV (intravenous) in FRa-low cohort
AZD5335 IV (intravenous) in FRa-high cohort
MIRV AIBW IV in FRa-high cohort
Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Ventana Medical Systems, Inc
Collaborator
GOG Foundation, Inc. (GOG Foundation)
Collaborator
European Network of Gynecological Oncological Trial Groups (ENGOT)
Collaborator
Citations
754P Initial results from a first-in-human study of AZD5335, ...
AZD5335 is an FRα-targeted antibody-drug conjugate that binds to FRα with high affinity and delivers a topoisomerase 1 inhibitor payload.
Derivation of AZD5335, a Novel FRα-Targeted TOP1i-Loaded ...
Results: A single dose of AZD5335 (2.5 mg/kg) achieved an overall response rate of 82% in patient-derived ovarian cancer xenografts (n = 17). ...
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and ...
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 ...
4.
aacrjournals.org
aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-1749/3660439/ccr-25-1749.pdf1 Derivation of AZD5335, a novel FRα-targeted TOP1i-loaded ...
Results: A single dose of AZD5335 (2.5mg/kg) achieved an overall response rate of 82% in ovarian cancer patient-derived xenografts (n=17). Anti-tumor responses ...
torvutatug samrotecan (AZD5335) / AstraZeneca
First-in-human study of AZD5335, a folate receptor α (FRα)-targeted antibody-drug conjugate, in patients with platinum-resistant recurrent ovarian cancer ...
Complete response to Mirvetuximab Soravtansine in platinum ...
This case report highlights an Aisan patient with ovarian cancer, who exhibited tolerance, recurrence, and progression after several prior lines of treatment.
7.
aacrjournals.org
aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-1749/3670148/ccr-25-1749.pdfDerivation of AZD5335, a Novel FRα-Targeted TOP1i-Loaded ...
Results: A single dose of AZD5335 (2.5 mg/kg) achieved an overall response rate of 82% in patient-derived ovarian cancer xenografts (n ¼ 17). Antitumor ...
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