NCT07322094PHASE1, PHASE2Recruiting
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
TORL Biotherapeutics, LLC
Start Date
12/10/2025
Completion Date
1/1/2028
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 Criteria
Age Range: 18 years to 75 years
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
Interventions
COMBINATION_PRODUCT
TORL-1-23 and paclitaxel
COMBINATION_PRODUCT
TORL-1-23 and carboplatin
COMBINATION_PRODUCT
TORL-1-23, paclitaxel, and carboplatin
Conditions
FIGO Stage III and IV Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Locations
Providence St. Jude Medical Center
Fullerton, California 92835
United States
City of Hope
Irvine, California 92618
United States
University of Southern California
Los Angeles, California 90007
United States
UCLA
Los Angeles, California 90095
United States
The Mayo Clinic
Rochester, Minnesota 55905
United States
Mt Sinai Hospital
New York, New York 10029
United States
Duke University
Durham, North Carolina 27705
United States