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

ConditionsFIGO Stage III and IV Ovarian Cancer Fallopian Tube Cancers Primary Peritoneal Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorTORL Biotherapeutics, LLC

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

Sponsors and collaborators

TORL Biotherapeutics, LLC

Lead sponsor

Source ClinicalTrials.gov