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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

UCLA
Los Angeles, California, 90095
Principal Investigator310-348-9636

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