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

July 9, 2026 updated by: TORL Biotherapeutics, LLC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
          • Principal Investigator
          • Phone Number: 310-348-9636
      • Los Angeles, California, United States, 90007
        • Recruiting
        • University of Southern California
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • The Mayo Clinic
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mt Sinai Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm A: TORL-1-23 and paclitaxel
Administered once every three weeks
Combination product: TORL-1-23 and paclitaxel
TORL-1-23 and paclitaxel
Experimental: Treatment Arm B: TORL-1-23 and carboplatin
Administered once every three weeks
Combination product: TORL-1-23 and carboplatin
TORL-1-23 and carboplatin
Experimental: Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin
Administered once every three weeks
Combination product: TORL-1-23, paclitaxel, and carboplatin
TORL-1-23, paclitaxel, and carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
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
postoperative after Cycle 4 (Each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the tolerability of TORL-1-23 in combination with chemotherapy
Time Frame: Treatment up to Cycle 8 (each cycle is 21 days)
Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE.
Treatment up to Cycle 8 (each cycle is 21 days)
To characterize duration of benefit for TORL-1-23 plus chemotherapy
Time Frame: Measured up to 15 months after surgery
Relapse free survival for participants
Measured up to 15 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TORL Biotherapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORL123-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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