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

Recruiting now · Phase 1/Phase 2

Conditions studied: FIGO Stage III and IV Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer

In brief

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

Key facts

Study ID

NCT07322094

Run by

TORL Biotherapeutics, LLC

People needed

60

Starts

2025-12-10

Expected to finish

2028-01-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence St. Jude Medical Center — Fullerton, California, United States (enrolling)
• City of Hope — Irvine, California, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• The Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Mt Sinai Hospital — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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