Treatment
This study consists of two different treatment options:
- Rinatabart Sesutecan (Rina-S)
- Standard therapy (paclitaxel, PLD, gemictabine or topotecan)
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Participants may be enrolled regardless of FRα expression level
- Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy
- Measurable disease, per RECIST v1.1
Main exclusion criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening
- Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06619236). 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