Treatment
FRα-high:
- AZD5335 is an FRα-targeted antibody-drug conjugate that binds to FRα with high affinity and delivers a topoisomerase 1 inhibitor payload.
- Mirvetuximab
FRα-low:
- AZD5335 is an FRα-targeted antibody-drug conjugate that binds to FRα with high affinity and delivers a topoisomerase 1 inhibitor payload.
- Paclitaxel or Pegylated liposomal doxorubicin or Topotecan
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main 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.
Main exclusion criteria:
- 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.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07218809). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be