CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
NCT06690775 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230
Last updated 2025-12-23
Summary
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
Conditions
- Epithelial Ovarian Cancer
- Primary Peritoneal
- Fallopian Tube Cancer
- Endometrioid Ovarian Cancer
Interventions
- DRUG
-
TORL-1-23
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DRUG
-
TORL-1-23
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DRUG
-
TORL-1-23
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DRUG
-
Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Sponsors & Collaborators
-
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
TORL Biotherapeutics, LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-20
- Primary Completion
- 2027-10-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- France
- Germany
- Ireland
- Italy
- Singapore
- South Korea
- Spain
Study Locations
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