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

Sponsor: TORL Biotherapeutics, LLC

Sponsor score: 0

ClinicalTrials ID:NCT07322094

CATALINA-4 is a Phase 1B/2 trial assessing the safety and efficacy of TORL-1-23 combined with chemotherapy in women with advanced ovarian cancer. Eligible participants must have a confirmed diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer, FIGO Stage III/IV, CLDN6 expression, ECOG ≤ 2, and adequate organ function. Interventions include combinations of TORL-1-23 with paclitaxel and/or carboplatin.

Patient Parameters

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Program Overview

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

Inclusion Criteria

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 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 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

Locations

FACILITY	ZIP	CITY	STATE
UCLA	90095	Los Angeles	California

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