NCT07322094RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 10 Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- TORL Biotherapeutics, LLC
- Diseases
- Ovarian cancer
- NCT number
- NCT07322094
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 10 Dec 2025 to the primary completion date, Dec 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic treatment for the disease under study
- Prior surgery
- Prior radiation therapy to the abdomen or pelvis
Other illness
- Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
- 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.
- Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases
Other
- Active, progressive, or symptomatic brain metastases
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Providence St. Jude Medical Center Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Mt Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| The Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.