NCT06690775

CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

Catalina-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: TORL Biotherapeutics, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-20
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2024-11-15
• Last updated: 2025-12-23

Locations

66 sites across 12 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Singapore, South Korea, Spain

Regulatory

• FDA-regulated drug study