CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

December 19, 2025 updated by: TORL Biotherapeutics, LLC

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

A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Melbourne
      • Clayton, Melbourne, Australia, VIC 3168
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
    • Queensland
      • Chermside, Queensland, Australia, QLD 4032
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
    • Western Australia
      • Perth, Western Australia, Australia, WA 6009
  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medizinische Universitat Landeskrankenhaus Graz
        • Contact:
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital (UZA)
        • Contact:
    • Brussels Capital
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-luc
        • Contact:
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
    • Wallonia
      • Liège, Wallonia, Belgium, B-4000
  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 0C2
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre - University Health Network (UHN)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C2
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B. Davis Jewish General Hospital
        • Contact:
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre (MUHC) - Royal Victoria Hospital
        • Contact:
      • Montreal, Quebec, Canada, H1T 2M4
  • France
    • Auvergne- Rhôn-Alpes
      • Lyon, Auvergne- Rhôn-Alpes, France, 69008
    • Pays de la Loire Region
      • Saint-Herblain, Pays de la Loire Region, France, 44805
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
  • Germany
    • Baden-Wurttenberg
      • Heidelberg, Baden-Wurttenberg, Germany, 69120
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13353
        • Recruiting
        • Charité Universitätsmedizin Berlin
        • Contact:
  • Ireland
    • Leinster
      • Dublin, Leinster, Ireland, D07 R2WY
        • Recruiting
        • Start Dublin - Mater Misericordiae University Hospital
        • Contact:
      • Dublin, Leinster, Ireland, DO8C9X2
  • Italy
    • Apulia
    • Milano
      • Milan, Milano, Italy, 20159
    • Prato
      • Prato, Prato, Italy, 59100
        • Recruiting
        • Nuovo Ospedale di Prato S Stefano
        • Contact:
    • Rome
      • Rome, Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, 119074
        • Recruiting
        • National University Cancer Institute
        • Contact:
      • Singapore, Singapore, Singapore, 168583
      • Singapore, Singapore, Singapore, 217562
  • South Korea
    • Gwanak-gu
      • Seoul, Gwanak-gu, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
    • Seocho-Gu
      • Seoul, Seocho-Gu, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
    • Seodaemun-Gu
      • Seoul, Seodaemun-Gu, South Korea, 03722
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
    • Songpa-Gu
      • Seoul, Songpa-Gu, South Korea, 05505
  • Spain
    • Catalonia
      • Girona, Catalonia, Spain, 17007
        • Recruiting
        • Institut Catala d'Oncologia de Girona
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • SCRI - Arizona Oncology Associates, PC-HOPE
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA - JCCC Clinical Research Unit
        • Contact:
      • Palo Alto, California, United States, 94304
      • Santa Barbara, California, United States, 93105
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Smilow Cancer Hospital at Yale - New Haven
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • SCRI - Maryland Oncology Hematology, P.A.
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • SCRI - Minnesota Oncology Hematology, P.A.
        • Contact:
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St Louis, Missouri, United States, 63108
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute - Ohio State University
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center at the University of Oklahoma
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • SCRI - Northwest Cancer Specialists, P.C.
        • Contact:
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Recruiting
        • SCRI - Alliance Cancer Specialists, PC
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104-4238
    • Texas
      • Fort Worth, Texas, United States, 76104
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • SCRI - Virginia Oncology Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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:

Participants are excluded from the study if any of the following criteria apply:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and investigator assessment
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Objective Response Rate (ORR)
Time Frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by investigator assessment
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Progression-free Survival (PFS)
Time Frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and by investigator assessment
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Overall Survival (OS)
Time Frame: From time of consent until death or completion of study (Study duration is approximately 40 months)
To assess additional efficacy outcome measures of TORL-1-23
From time of consent until death or completion of study (Study duration is approximately 40 months)
Incidence and severity of AEs and clinical laboratory abnormalities per CTCAE v5.0
Time Frame: From informed consent until 30 days after the last dose of study treatment, approximately 24 months (each cycle is 21 days)
To assess the safety and tolerability of TORL-1-23
From informed consent until 30 days after the last dose of study treatment, approximately 24 months (each cycle is 21 days)
CA-125 response per Gynecological Cancer Intergroup (GCIG) criteria
Time Frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
To assess the pharmacodynamic effects of TORL-1-23
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TORL Biotherapeutics, LLC

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORL123-002
  • 2024-517190-24-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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