CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
NCT ID: NCT06690775
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2024-11-20
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.
TORL-1-23
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Cohort 2
Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.
TORL-1-23
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Cohort 3
Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.
TORL-1-23
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Interventions
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TORL-1-23
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.
Eligibility Criteria
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Inclusion Criteria
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 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.
Exclusion Criteria
1. Has not recovered \[recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
2. Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers.
3. Participants with primary platinum-refractory ovarian, primary peritoneal (i.e. of primary origin) or fallopian tube cancer, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.
4. Received prior chemotherapeutic, investigational, radiotherapy, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23. There is no waiting period required for stereotactic radiosurgery.
5. Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.
6. Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.
7. Grade 2 or greater peripheral neuropathy.
8. History of non-infectious pneumonitis/ILD within 6 months of first dose of study drug.
9. Participants must not be considered a high medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
10. History of significant cardiac disease:
1. Congestive heart failure \>New York Heart Association class 2 within last year
2. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
3. Myocardial infarction less than 6 months before start of study drug
4. Anti-arrhythmic therapy (beta blockers are permitted)
5. Any unstable ischemic disease or untreated arrhythmia
11. Known history of myelodysplastic syndrome or acute myeloid leukemia.
12. History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. Participants with malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ of the breast are not excluded.
13. Uncontrolled infection; active, clinically serious infections (CTCAE Grade \>2).
14. Participants with seizure disorder requiring medication.
15. Known hypersensitivity or intolerance to any of the study drugs, study drug classes, or excipients in the formulation.
16. History of having an allogeneic bone marrow or organ transplant.
17. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator.
18. Participants who are taking any drugs that are strong inducers and/or strong inhibitors of CYP3A4 enzymes.
19. Participants who are taking any drugs that are inhibitors of P-glycoprotein.
18 Years
FEMALE
No
Sponsors
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
TORL Biotherapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
SCRI - Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Providence St. Jude Medical Center
Fullerton, California, United States
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
SCRI - Sansum Clinic
Santa Barbara, California, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
SCRI - Maryland Oncology Hematology, P.A.
Annapolis, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
SCRI - Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Duke Cancer Center
Durham, North Carolina, United States
The James Cancer Hospital and Solove Research Institute - Ohio State University
Columbus, Ohio, United States
Stephenson Cancer Center at the University of Oklahoma
Oklahoma City, Oklahoma, United States
SCRI - Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
SCRI - Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
SCRI - Texas Oncology
Fort Worth, Texas, United States
SCRI - Virginia Oncology Associates
Norfolk, Virginia, United States
Monash Medical Centre
Clayton, Melbourne, Australia
Blacktown Hospital
Blacktown, New South Wales, Australia
Icon Cancer Centre Chermside
Chermside, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Linear Clinical Research
Perth, Western Australia, Australia
Medizinische Universitat Landeskrankenhaus Graz
Graz, Styria, Austria
Universitatsklinik Innsbruck
Innsbruck, Tyrol, Austria
Ordensklinikum Linz
Linz, Upper Austria, Austria
Antwerp University Hospital (UZA)
Edegem, Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Leuven
Leuven, Flemish Brabant, Belgium
CHU Liège
Liège, Wallonia, Belgium
BC Cancer - Abbotsford
Abbotsford, British Columbia, Canada
British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)
Vancouver, British Columbia, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network (UHN)
Toronto, Ontario, Canada
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, Canada
Centre Leon Berard
Lyon, Auvergne- Rhôn-Alpes, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Pays de la Loire Region, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Universitatsklinikum Heidelberg
Heidelberg, Baden-Wurttenberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Start Dublin - Mater Misericordiae University Hospital
Dublin, Leinster, Ireland
St. James Hospital
Dublin, Leinster, Ireland
IRCCS Giovani Paolo II - Instituto Oncologico
Bari, Apulia, Italy
Humanitas San Pio X
Milan, Milano, Italy
Nuovo Ospedale di Prato S Stefano
Prato, Prato, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Rome, Italy
National University Cancer Institute
Singapore, Singapore, Singapore
National Cancer Centre
Singapore, Singapore, Singapore
Curie Oncology (Farrer)
Singapore, Singapore, Singapore
Seoul National University Hospital
Seoul, Gwanak-gu, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho-Gu, South Korea
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-Gu, South Korea
Asan Medical Center
Seoul, Songpa-Gu, South Korea
Institut Catalá d'Oncologia de Girona
Girona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Prinicpal Investigator
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Other Identifiers
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TORL123-002
Identifier Type: -
Identifier Source: org_study_id
2024-517190-24-00
Identifier Type: CTIS
Identifier Source: secondary_id