Summary

Eligibility
for females ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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

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

Keywords

FIGO Stage III and IV Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer, Fallopian Tube Neoplasms, Paclitaxel, Carboplatin, TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin, TORL-1-23, paclitaxel, and carboplatin

Eligibility

You can join if…

Open to females ages 18-75

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of Southern California accepting new patients
    Los Angeles California 90007 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TORL Biotherapeutics, LLC
Links
Sign up for this study
ID
NCT07322094
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated