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NCT Number: 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

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

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Key information

Conditions

FIGO Stage III and IV Ovarian Cancer Adnexal Diseases Fallopian Tube Cancers Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Providence St. Jude Medical Center, Fullerton, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TORL-1-23 and paclitaxel

Combination Product

TORL-1-23 and paclitaxel

TORL-1-23 and carboplatin

Combination Product

TORL-1-23 and carboplatin

TORL-1-23, paclitaxel, and carboplatin

Combination Product

TORL-1-23, paclitaxel, and carboplatin

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Labib, PharmD

CONTACT

[email protected]

310-348-9636

Sponsors and collaborators

Lead sponsor

TORL Biotherapeutics, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 7, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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