OncoMatch/Clinical Trials/NCT06690775
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Is NCT06690775 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TORL-1-23 and TORL-1-23 for epithelial ovarian cancer.
Treatment: TORL-1-23 · TORL-1-23 · TORL-1-23 · Pegfilgrastim (drug) — A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: CLDN6 overexpression (positive as defined by the CLDN6 reference laboratory assay)
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.
Disease stage
Metastatic disease required
Grade: high grade
advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer. Measurable disease, per RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Participants must have platinum-resistant disease, defined as...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.
Cannot have received: CLDN6-targeting agent
Prior treatment with a CLDN6-targeting agent
Cannot have received: MMAE-containing antibody-drug conjugate
Prior treatment with...an MMAE-containing ADC
Lab requirements
Blood counts
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
Kidney function
Measured or calculated creatinine clearance with a validated formula: ≥30 mL/min
Liver function
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
Cardiac function
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
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital · Phoenix, Arizona
- SCRI - Arizona Oncology Associates, PC-HOPE · Tucson, Arizona
- City of Hope National Medical Center · Duarte, California
- Providence St. Jude Medical Center · Fullerton, California
- UCLA - JCCC Clinical Research Unit · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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