NCT06690775 · TORL Biotherapeutics, LLC
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
What this study is about
A Phase 2 study to evaluate the safety and effectiveness of TORL-1-23 in patients with advanced ovarian cancer.
View original scientific description
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced 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.
Primary outcome measures
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, primary peritoneal (i.e, of primary origin), or fallopian tube cancer. High-grade endometrioid ovarian cancer is permitted for enrollment.
- Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay. Tumor tissue will be required for submission for CLDN6 testing prior to Cycle 1 Day 1.
- Participants must have platinum-resistant disease, defined
Where
- Phoenix, Arizona
- Tucson, Arizona
- Duarte, California
- Fullerton, California
- Los Angeles, California
- Palo Alto, California
- Santa Barbara, California
- New Haven, Connecticut
- Jacksonville, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Annapolis, Maryland
And 13 more locations — see the full list below.
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations