RecruitingPhase 1Phase 2NCT07322094

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

CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer


Sponsor

TORL Biotherapeutics, LLC

Enrollment

60 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study — called CATALINA-4 — is testing a new drug called TORL-1-23 given alongside standard chemotherapy before surgery in women with advanced ovarian cancer. The drug targets a protein called claudin-6 (CLDN6) that is found on many ovarian cancer cells, and researchers hope it can shrink tumors enough to make surgery more effective. **You may be eligible if...** - You have been diagnosed with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer (Stage III or IV) - Your tumor tests positive for the claudin-6 (CLDN6) protein - You have not yet received any treatment for this cancer - You have not had prior surgery or radiation to the abdomen or pelvis - You are in reasonably good health (ECOG performance status ≤ 2) **You may NOT be eligible if...** - You have a rare subtype of ovarian cancer (clear cell, mucinous, sarcomatous, low-grade/borderline, or non-epithelial) - You have received prior treatment for this cancer - You have active or worsening brain metastases - You are pregnant or breastfeeding - You have serious uncontrolled medical conditions or active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTORL-1-23 and paclitaxel

TORL-1-23 and paclitaxel

COMBINATION_PRODUCTTORL-1-23 and carboplatin

TORL-1-23 and carboplatin

COMBINATION_PRODUCTTORL-1-23, paclitaxel, and carboplatin

TORL-1-23, paclitaxel, and carboplatin


Locations(1)

UCLA

Los Angeles, California, United States

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NCT07322094


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