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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 1/2Sponsored by TORL Biotherapeutics, LLC
Actively Recruiting
PhasePhase 1/2
SponsorTORL Biotherapeutics, LLC
Started2025-12-10
Est. completion2027-12
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07322094
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
Age: 18 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
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
Conditions4
CancerFIGO Stage III and IV Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Locations1 site
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1/2
SponsorTORL Biotherapeutics, LLC
Started2025-12-10
Est. completion2027-12
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07322094