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
NCT ID: NCT07322094
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2025-12-10
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm A: TORL-1-23 and paclitaxel
Administered once every three weeks
TORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
Treatment Arm B: TORL-1-23 and carboplatin
Administered once every three weeks
TORL-1-23 and carboplatin
TORL-1-23 and carboplatin
Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin
Administered once every three weeks
TORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Interventions
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TORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
TORL-1-23 and carboplatin
TORL-1-23 and carboplatin
TORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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TORL Biotherapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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UCLA
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Other Identifiers
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TORL123-004
Identifier Type: -
Identifier Source: org_study_id
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