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Recruiting 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

Phase I / Phase II Interventional FIGO Stage III and IV Ovarian Cancer Fallopian Tube Cancers Primary Peritoneal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin, TORL-1-23, paclitaxel, and carboplatin.
Who it may be relevant to
Registry conditions: FIGO Stage III and IV Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Combination product TORL-1-23 and paclitaxel
    TORL-1-23 and paclitaxel
  • Combination product TORL-1-23 and carboplatin
    TORL-1-23 and carboplatin
  • Combination product TORL-1-23, paclitaxel, and carboplatin
    TORL-1-23, paclitaxel, and carboplatin

Primary outcome 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. [Time frame: 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)]
Secondary outcome measures (2)
  • To assess the tolerability of TORL-1-23 in combination with chemotherapy [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Providence St. Jude Medical Center — Fullerton
  • City of Hope — Irvine
  • University of Southern California — Los Angeles
  • UCLA — Los Angeles
  • The Mayo Clinic — Rochester
  • Mt Sinai Hospital — New York
  • Duke University — Durham

Identifiers

NCT: NCT07322094 · TORL123-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗