Home › Ovarian Cancer › NCT07322094
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
RecruitingPhase 1/2
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
Who can join
Ages 18 to 75 · Women
Full eligibility criteria
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
About the study
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
What is being tested
- TORL-1-23 and paclitaxel (combination product)
- TORL-1-23 and carboplatin (combination product)
- TORL-1-23, paclitaxel, and carboplatin (combination product)
Sponsor: TORL Biotherapeutics, LLC · Participants: 60 · Started: Dec 10, 2025
Contact the study team
- Caroline Labib, PharmD · Phone: 310-348-9636
Official record on ClinicalTrials.gov — NCT07322094
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.