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
TORL Biotherapeutics, LLC
Summary
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Females ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent. 2. Participants must sign the informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Disease Type: * Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, prim…
Interventions
- DrugTORL-1-23
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DrugTORL-1-23
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DrugTORL-1-23
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
- DrugPegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Locations (66)
- Mayo Clinic HospitalPhoenix, Arizona
- SCRI - Arizona Oncology Associates, PC-HOPETucson, Arizona
- City of Hope National Medical CenterDuarte, California
- Providence St. Jude Medical CenterFullerton, California
- UCLA - JCCC Clinical Research UnitLos Angeles, California
- Stanford Cancer CenterPalo Alto, California