Clinical Trial

A Phase 2 Study Evaluating The Efficacy And Safety Of TORL-1-23 In Women With Advanced Platinum Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal And Fallopian Tube Cancers) Expressing Claudin 6 (CLND6) (TORL123-002)

MOA: TORL-1-23 is an ADC that targets CLDN6 and contains a MMAE payload.

Key Eligibility Criteria:

• Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous OC/PP/FPC
• High-grade endometrioid permitted
• Clear cell, mucinous, sarcomatous (incl carcinosarcoma), mixed histology, low grade, borderline ovarian tumors, non-epithelial ovarian cancers excluded
• Pt must have platinum-resistant disease
• Primary plt-refractory excluded
• 1-3 prior systemic lines of therapy, eligible for single-agent as next tx
• Prior bevacizumab for treatment of OC per label required unless ineligible
• Prior MIRV required for FOLR1-high (FRα ≥ 75%) disease unless ineligible
• Prior PARPi maintenance required for pts with BRCA mutation unless ineligible
• Prior tx with CLDN6-targeting agent or MMAE-containing ADC excluded
• Tumor must be CLDN6+ (>30% tumor cell membrane staining of any intensity by IHC)
• Measurable disease per RECIST v1.1