NCT07322094 · TORL Biotherapeutics, LLC
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
What this study is about
A Phase 1B/2 Study to Investigate the Safety and effectiveness of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
View original scientific description
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
Interventions
COMBINATION_PRODUCT
TORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
COMBINATION_PRODUCT
TORL-1-23 and carboplatin
TORL-1-23 and carboplatin
COMBINATION_PRODUCT
TORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Primary outcome measures
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
Time frame: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)
To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy
Time frame: postoperative after Cycle 4 (Each cycle is 21 days)
Determination of percentage CRS3 score for each treatment arm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Fullerton, California
- Irvine, California
- Los Angeles, California
- Rochester, Minnesota
- New York, New York
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations