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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

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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