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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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsFemaleTORL Biotherapeutics, LLC
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • TORL-1-23 and paclitaxel
  • TORL-1-23 and carboplatin
  • TORL-1-23, paclitaxel, and carboplatin
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Where

7 sites
Providence St. Jude Medical Center
Fullerton, United States
City of Hope
Irvine, United States
University of Southern California
Los Angeles, United States
UCLA
Los Angeles, United States
The Mayo Clinic
Rochester, United States
Mt Sinai Hospital
New York, United States
Duke University
Durham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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