Clinical Trial

CATALINA-2: 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

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)
• FOLR1 status must be collected prior to enrollment
• Measurable disease per RECIST v1.1