CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer

CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer

A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer
• FIGO Stage III or IV
• Positive for claudin 6 (CLDN6) expression
• Adequate organ function

Exclusion Criteria:

• Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
• Prior systemic treatment for the disease under study
• Prior surgery
• Prior radiation therapy to the abdomen or pelvis
• Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication.
• History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug.
• Active, progressive, or symptomatic brain metastases
• Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases
• Pregnant or breastfeeding women