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

About

Brief 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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

Female

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

70 Years

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
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 chemotherapy, biologic/targeted therapy, immunomodulator therapy for any disease indication
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