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

Purpose

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

Conditions

  • FIGO Stage III and IV Ovarian Cancer
  • Fallopian Tube Cancers
  • Primary Peritoneal Cancer

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Arm A: TORL-1-23 and paclitaxel 		Administered once every three weeks
  • Combination Product: TORL-1-23 and paclitaxel
    TORL-1-23 and paclitaxel
Experimental
Treatment Arm B: TORL-1-23 and carboplatin 		Administered once every three weeks
  • Combination Product: TORL-1-23 and carboplatin
    TORL-1-23 and carboplatin
Experimental
Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin 		Administered once every three weeks
  • Combination Product: TORL-1-23, paclitaxel, and carboplatin
    TORL-1-23, paclitaxel, and carboplatin

Recruiting Locations

Providence St. Jude Medical Center
Fullerton, California 92835

City of Hope
Irvine, California 92618

University of Southern California
Los Angeles, California 90007

UCLA
Los Angeles, California 90095
Contact:
Principal Investigator
310-348-9636

The Mayo Clinic
Rochester, Minnesota 55905

Mt Sinai Hospital
New York, New York 10029

Duke University
Durham, North Carolina 27705

More Details

Status
Recruiting
Sponsor
TORL Biotherapeutics, LLC

Study Contact

Caroline Labib, PharmD
310-348-9636
caroline.labib@torlbio.com