Treatment
The treatment option in this study is TORL-1-23.
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer. High-grade endometrioid ovarian cancer is permitted for enrollment
- Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay. Tumor tissue will be required for submission for CLDN6 testing prior to Cycle 1 Day 1
- Participants must have platinum-resistant disease
- Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy
- Participants must have received prior bevacizumab for treatment of ovarian cancer per the label, unless the participant is not eligible due to precautions or intolerance
- Measurable disease, per RECIST v1.1
Main exclusion criteria:
- Participants with primary platinum-refractory ovarian, primary peritoneal or fallopian tube cancer, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.
- History of non-infectious pneumonitis/ILD within 6 months of first dose of study drug.
- Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC
Disclaimer: 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