Epithelial Ovarian CancerPhase 2NCT06690775
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
A Phase 2 study testing TORL-1-23 and Pegfilgrastim (drug) in people with Epithelial Ovarian Cancer and Primary Peritoneal, run by TORL Biotherapeutics, LLC at 66 sites in 12 countries.
Trial summary
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer
- What is being tested?
- TORL-1-23 and Pegfilgrastim (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 66 sitesin 12 countries
- Study dates
- 20 Nov 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all the following criteria apply:
- 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.
- 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.
- 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.
Show all 32Show fewer
- 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
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- 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.
- 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.
- 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.
- Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment.
- Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- 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.
- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers.
- 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.
- 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.
- Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.
Show all 25Show fewer
- 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.
- Grade 2 or greater peripheral neuropathy.
- History of non-infectious pneumonitis/ILD within 6 months of first dose of study drug.
- 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.
- History of significant cardiac disease:
- Congestive heart failure >New York Heart Association class 2 within last year
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before start of study drug
- Anti-arrhythmic therapy (beta blockers are permitted)
- Any unstable ischemic disease or untreated arrhythmia
- Known history of myelodysplastic syndrome or acute myeloid leukemia.
- 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.
- Uncontrolled infection; active, clinically serious infections (CTCAE Grade >2).
- Participants with seizure disorder requiring medication.
- Known hypersensitivity or intolerance to any of the study drugs, study drug classes, or excipients in the formulation.
- History of having an allogeneic bone marrow or organ transplant.
- 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.
- Participants who are taking any drugs that are strong inducers and/or strong inhibitors of CYP3A4 enzymes.
- Participants who are taking any drugs that are inhibitors of P-glycoprotein.
Trial locations and contacts
66 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 12 countries
United States26 sites, 26 recruiting
- Recruiting
SCRI - Maryland Oncology Hematology, P.A.
Annapolis, Maryland, 21401
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
The James Cancer Hospital and Solove Research Institute - Ohio State University
Columbus, Ohio, 43210
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, 18901
Principal Investigator, MD, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Texas Oncology
Fort Worth, Texas, 76104
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Providence St. Jude Medical Center
Fullerton, California, 92835
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
UCLA - JCCC Clinical Research Unit
Los Angeles, California, 90095
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55404
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, 06510
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Virginia Oncology Associates
Norfolk, Virginia, 23502
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Stephenson Cancer Center at the University of Oklahoma
Oklahoma City, Oklahoma, 73104
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4238
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Sansum Clinic
Santa Barbara, California, 93105
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Washington University
St Louis, Missouri, 63108
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
SCRI - Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, 85711
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Canada8 sites, 8 recruiting
- Recruiting
BC Cancer - Abbotsford
Abbotsford British Columbia, British Columbia, V2S 0C2
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Hospital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C2
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Princess Margaret Cancer Centre - University Health Network (UHN)
Toronto, Ontario, M5G 2M9
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)
Vancouver, British Columbia, V5Z 4E6
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Australia5 sites, 5 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Icon Cancer Centre Chermside
Chermside, Queensland, QLD 4032
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Monash Medical Centre
Clayton, Melbourne, VIC 3168
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Linear Clinical Research
Perth, Western Australia, WA 6009
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Belgium4 sites, 4 recruiting
- Recruiting
Antwerp University Hospital (UZA)
Edegem, Antwerp, 2650
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
UZ Leuven
Leuven, Flemish Brabant, 3000
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
CHU Liège
Liège, Wallonia, B-4000
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Giovani Paolo II - Instituto Oncologico
Bari, Apulia, 70124
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
CATALINA-2-Study@torlbio.com
- Recruiting
Humanitas San Pio X
Milan, Milano, 20159
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Nuovo Ospedale di Prato S Stefano
Prato, Prato, 59100
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Rome, 00168
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Gwanak-gu, 03080
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho-Gu, 06591
Prinicpal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-Gu, 03722
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Asan Medical Center
Seoul, Songpa-Gu, 05505
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universitat Landeskrankenhaus Graz
Graz, Styria, 8036
Princiapl Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Universitatsklinik Innsbruck
Innsbruck, Tyrol, 6020
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Ordensklinikum Linz
Linz, Upper Austria, 4010
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
France3 sites, 3 recruiting
- Recruiting
Centre Leon Berard
Lyon, Auvergne- Rhôn-Alpes, 69008
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, Pays de la Loire Region, 44805
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94805
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Germany3 sites, 3 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Universitatsklinikum Heidelberg
Heidelberg, Baden-Wurttenberg, 69120
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Singapore3 sites, 3 recruiting
- Recruiting
National University Cancer Institute
Singapore, Singapore, 119074
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
National Cancer Centre
Singapore, Singapore, 168583
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
Curie Oncology (Farrer)
Singapore, Singapore, 217562
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Ireland2 sites, 2 recruiting
- Recruiting
Start Dublin - Mater Misericordiae University Hospital
Dublin, Leinster, D07 R2WY
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
- Recruiting
St. James Hospital
Dublin, Leinster, DO8C9X2
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
Spain1 site, 1 recruiting
- Recruiting
Institut Catalá d'Oncologia de Girona
Girona, Catalonia, 17007
Principal Investigator, 310-348-9636, CATALINA-2-Study@torlbio.com
About this study
Official title: 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.
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Endometrioid Ovarian Cancer
- Being tested
- TORL-1-23, Pegfilgrastim (drug)
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORL-1-23Drug
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23Drug
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23Drug
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)Drug
6.0 mg subcutaneous injection on Day 4 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: TORL-1-23; Drug: Pegfilgrastim (drug) |
| Cohort 2 | Experimental | 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. Receives: Drug: TORL-1-23; Drug: Pegfilgrastim (drug) |
| Cohort 3 | Experimental | 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. Receives: Drug: TORL-1-23; Drug: Pegfilgrastim (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6
Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Secondary outcomes (6)
Duration of Response (DOR)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and investigator assessment
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Objective Response Rate (ORR)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by investigator assessment
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Progression-free Survival (PFS)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and by investigator assessment
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Overall Survival (OS)
To assess additional efficacy outcome measures of TORL-1-23
Measured: 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
To assess the safety and tolerability of TORL-1-23
Measured: 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
To assess the pharmacodynamic effects of TORL-1-23
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start20 Nov 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TORL Biotherapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690775
- Sponsor's protocol ID
- TORL123-002
- Other IDs
- 2024-517190-24-00
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06690775
- Acronym / sponsor ID
- TORL123-002
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Endometrioid Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- TORL Biotherapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TORL-1-23, Drug: Pegfilgrastim (drug)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. |
| Cohort 2 | Experimental | Drug: TORL-1-23, Drug: Pegfilgrastim (drug)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. |
| Cohort 3 | Experimental | Drug: TORL-1-23, Drug: Pegfilgrastim (drug)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Participants are eligible to be included in the study only if all the following criteria apply:
- 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.
- 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.
- Disease Type:
- Measurable disease, per RECIST v1.1
Key exclusion criteria (25 listed)
- 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.
- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers.
- 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.
- 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.
- Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORL-1-232.4mg/kg intravenous infusion on Day 1 of every 3-week cycle. | Drug | Cohort 1 |
| TORL-1-233.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle. | Drug | Cohort 2 |
| TORL-1-233.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle. | Drug | Cohort 3 |
| Pegfilgrastim (drug)6.0 mg subcutaneous injection on Day 4 of each cycle. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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)
6 secondary outcomes
Duration of Response (DOR)
Time frame: 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
Progression-free Survival (PFS)
Time frame: 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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Epithelial Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
66 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TORL-1-23 and Pegfilgrastim (drug) in people with Epithelial Ovarian Cancer and Primary Peritoneal, run by TORL Biotherapeutics, LLC at 66 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada, Australia, Belgium, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatem Dokainish, PhD (310-348-9636, CATALINA-2-Study@torlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.