RecruitingPhase 1Phase 2NCT07322094
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
Sponsor
TORL Biotherapeutics, LLC
Enrollment
60 participants
Start Date
Dec 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years
Inclusion Criteria5
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- 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 Criteria8
- 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 chemotherapy, biologic/targeted therapy, immunomodulator therapy for any disease indication
- 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
Interventions
COMBINATION_PRODUCTTORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
COMBINATION_PRODUCTTORL-1-23 and carboplatin
TORL-1-23 and carboplatin
COMBINATION_PRODUCTTORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07322094
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