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

TORL Biotherapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Fallopian Tube Cancers; Primary Peritoneal Cancer; FIGO Stage III and IV Ovarian Cancer

Treatments: Combination Product: TORL-1-23, paclitaxel, and carboplatin; Combination Product: TORL-1-23 and paclitaxel; Combination Product: TORL-1-23 and carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07322094

TORL123-004

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Treatment Arm A: TORL-1-23 and paclitaxel

Experimental group

Description:

Administered once every three weeks

Treatment:

Combination Product: TORL-1-23 and paclitaxel

Treatment Arm B: TORL-1-23 and carboplatin

Experimental group

Description:

Administered once every three weeks

Treatment:

Combination Product: TORL-1-23 and carboplatin

Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin

Experimental group

Description:

Administered once every three weeks

Treatment:

Combination Product: TORL-1-23, paclitaxel, and carboplatin