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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2028-01-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm A: TORL-1-23 and paclitaxel

Administered once every three weeks

Group Type EXPERIMENTAL

TORL-1-23 and paclitaxel

Intervention Type COMBINATION_PRODUCT

TORL-1-23 and paclitaxel

Treatment Arm B: TORL-1-23 and carboplatin

Administered once every three weeks

Group Type EXPERIMENTAL

TORL-1-23 and carboplatin

Intervention Type COMBINATION_PRODUCT

TORL-1-23 and carboplatin

Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin

Administered once every three weeks

Group Type EXPERIMENTAL

TORL-1-23, paclitaxel, and carboplatin

Intervention Type COMBINATION_PRODUCT

TORL-1-23, paclitaxel, and carboplatin

Interventions

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TORL-1-23 and paclitaxel

TORL-1-23 and paclitaxel

Intervention Type COMBINATION_PRODUCT

TORL-1-23 and carboplatin

TORL-1-23 and carboplatin

Intervention Type COMBINATION_PRODUCT

TORL-1-23, paclitaxel, and carboplatin

TORL-1-23, paclitaxel, and carboplatin

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TORL Biotherapeutics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Caroline Labib, PharmD

Role: CONTACT

310-348-9636

Facility Contacts

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Principal Investigator

Role: primary

310-348-9636

Other Identifiers

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TORL123-004

Identifier Type: -

Identifier Source: org_study_id

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