About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 3 treatment groups

Locations

7
Providence St. Jude Medical Center92835, FullertonCalifornia, United States
City of Hope92618, IrvineCalifornia, United States
UCLA90095, Los AngelesCalifornia, United States
University of Southern California90007, Los AngelesCalifornia, United States

Sponsors and collaborators

TORL Biotherapeutics, LLC

Lead sponsor