Treatment
Part A: Platinum resistent disease:
- Sofetabart Mipitecan (LY4170156)
Investigator's choice: paclitaxel, PLD, gemcitabine or topotecan
Part B: Platinum sensitive disease:
- Sofetabart Mipitecan (LY4170156) + bevacizumab
- Investigator's choice: carboplatin/paclitaxel or carboplatin/gemcitabine or carboplatin/PLD + bevacizumab
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
Part A and B:
- Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
- Have confirmed availability of tumor tissue block or slides
- Have measurable disease per RECIST v1.1
Part A:
- Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
- Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.
- Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
Part B:
- Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (>)6 months of their last administration of platinum therapy
- Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy
Main exclusion criteria:
- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07213804). 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