CATALINA-2: A Study of TORL-1-23 for Platinum-Resistant Ovarian Cancer
This study, called CATALINA-2, is testing a drug called TORL-1-23 in women with advanced ovarian cancer that has come back or worsened after platinum-based chemotherapy (platinum-resistant ovarian cancer). You would receive TORL-1-23 as an intravenous (IV) infusion every three weeks, possibly along with another drug called Pegfilgrastim given as a shot. The main goal is to see how well TORL-1-23 works to shrink tumors or stop them from growing in patients whose cancer cells have a specific marker called CLDN6. This study is looking for about 230 women aged 18 or older.
- Study design
- This is a Phase 2 study, meaning it's evaluating the safety and effectiveness of TORL-1-23. It aims to enroll about 230 participants.
- What's involved
- You would receive TORL-1-23 as an intravenous infusion on Day 1 of every 3-week cycle. You might also receive Pegfilgrastim as a subcutaneous (under the skin) injection on Day 4 of each cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored at regular intervals from the first dose until your disease worsens, for a total study duration of about 40 months.
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NCT06690775
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Recruiting
PHASE2Ages 18+InterventionalTreatmentTORL Biotherapeutics, LLC
~230 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:TORL-1-23Pegfilgrastim (drug)
At a glance
Recruiting sites
66 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6
Measured over At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Conditions
Where it's being run
66 sites across 50 statesCalifornia5
Quebec4
Minnesota3
Singapore3
Arizona2
Pennsylvania2
British Columbia2
Ontario2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 as the following:
If participants received only 1 line of platinum-based therapy, they must have completed 4 or more cycles of platinum-containing therapy, must have achieved a CR or PR, and progressed \>3 months but ≤6 months after the last dose of platinum.
Participants who have received more than 1 line of platinum- based therapy must have progressed on or within 6 months after the last dose of platinum.
NOTE: This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression (per RECIST v1.1).
Participants who are platinum-refractory during front-line treatment are excluded.
Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single- agent therapy is appropriate as the next line of treatment. Study rules for evaluation of number of prior systemic lines of therapy:
Adjuvant ± neoadjuvant is considered one line of therapy
Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
Hormonal therapy will not be counted as a separate line of therapy 4. Measurable disease, per RECIST v1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 6. Adequate organ function, based on the following laboratory values:
ANC: ≥1,500/mcL
Platelets: ≥100,000/mcL without transfusion within 4 weeks of first dose
Hemoglobin: 9 g/dL with transfusion or EPO support up to 14 days before eligibility assessment
Measured or calculated creatinine clearance with a validated formula\*: ≥30 mL/min
Serum total bilirubin: ≤1.5 X ULN (participants with known Gilbert disease or liver metastases who have serum bilirubin level ≤3×ULN may be enrolled
AST (SGOT) and ALT (SGPT): ≤3 X ULN (participants with active liver metastases who have ALT/AST ≤5 X ULN may be enrolled)
Albumin: ≥2.5 g/dL
ECG: 12-Lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention and QTcF interval
470 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality. 7. Participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug treatment. The serum pregnancy test must be negative for the participant to be eligible. 8. Participants must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment, or be of nonchildbearing potential. 9. Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment. 10. Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.
What this trial measures
- To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6At 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)