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CATALINA-4: TORL-1-23 with Chemotherapy for Advanced Ovarian Cancer

This study, CATALINA-4, is looking at a new treatment called TORL-1-23 given with chemotherapy (paclitaxel and/or carboplatin) before surgery for women with advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers want to see how safe this combination is and how well it works to shrink tumors. You might be able to join if you are a woman between 18 and 75 years old, have advanced stage III or IV cancer, and your cancer cells show a specific marker called claudin 6 (CLDN6). The study aims to understand side effects and how effective the treatment is after surgery. The current status of this study is unclear, and it plans to enroll about 60 participants.

Study design
This is a Phase 1B/2 study, meaning it's looking at both safety and effectiveness. It involves giving a new treatment combination before surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Efficacy is measured after surgery, following 4 cycles of treatment (each 21 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07322094

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
PHASE1Ages 18–75InterventionalTreatment
TORL Biotherapeutics, LLC
~60 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:TORL-1-23 and paclitaxelTORL-1-23 and carboplatinTORL-1-23, paclitaxel, and carboplatin

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
+1 more outcome measured

Conditions

FIGO Stage III and IV Ovarian Cancer
Fallopian Tube Cancers
Primary Peritoneal Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerCLDN6 Gene

Where it's being run

7 sites across 4 states
California4
Minnesota1
New York1
North Carolina1

Who to contact

Caroline Labib, PharmD
[email protected]
310-348-9636
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial 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.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 chemotherapypostoperative after Cycle 4 (Each cycle is 21 days)

    Determination of percentage CRS3 score for each treatment arm