Actively Recruiting
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Led by TORL Biotherapeutics, LLC · Updated on 2025-12-23
230
Participants Needed
66
Research Sites
158 weeks
Total Duration
On this page
Sponsors
T
TORL Biotherapeutics, LLC
Lead Sponsor
E
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
CONDITIONS
Official Title
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older at the time of consent
- Signed informed consent and agreement to study requirements
- Histologically or cytologically confirmed advanced or metastatic high-grade serous ovarian, primary peritoneal, or fallopian tube cancer; high-grade endometrioid ovarian cancer allowed
- Tumor must be positive for CLDN6 expression confirmed by reference laboratory assay
- Platinum-resistant disease defined by progression more than 3 but no more than 6 months after last platinum dose if only 1 prior platinum therapy; or progression on or within 6 months after last platinum dose if more than 1 prior therapy
- Received at least 1 but no more than 3 prior systemic anticancer therapy lines; single-agent therapy appropriate next step
- Measurable disease per RECIST v1.1
- ECOG performance status 0 or 1
- Adequate organ function including ANC ≥1500/mcL, platelets ≥100,000/mcL without recent transfusion, hemoglobin ≥9 g/dL with support allowed, creatinine clearance ≥30 mL/min, bilirubin ≤1.5 x ULN (exceptions for Gilbert disease or liver metastases), AST/ALT ≤3 x ULN (≤5 x ULN if liver metastases), albumin ≥2.5 g/dL
- Normal or non-clinically significant ECG with QTcF ≤470 msec and no history of symptomatic QTc abnormalities
- Negative serum pregnancy test within 72 hours before treatment if of childbearing potential
- Agreement to use highly effective birth control from first treatment through 7 months after last treatment or be of nonchildbearing potential
- Agreement not to donate eggs from first treatment through 7 months after last treatment
- Agreement not to breastfeed from first dose through 90 days after last dose
You will not qualify if you...
- Not recovered from acute toxicities of prior therapy except alopecia or eligible lab abnormalities
- Clear cell, mucinous, sarcomatous, mixed histology, low-grade, borderline ovarian tumors, or non-epithelial ovarian cancers
- Primary platinum-refractory disease defined as progression within 3 months of first-line platinum therapy
- Received cancer treatment within 14 days for small molecules or 28 days for biologics before first TORL-1-23 dose (no wait for stereotactic radiosurgery)
- Prior treatment with CLDN6-targeting agent or MMAE-containing ADC
- Progressive or symptomatic brain metastases; stable treated brain metastases allowed; leptomeningeal disease excluded
- Grade 2 or higher peripheral neuropathy
- History of non-infectious pneumonitis or interstitial lung disease within 6 months
- Serious uncontrolled medical disorders, infections, or psychiatric conditions prohibiting consent
- Significant cardiac disease including recent congestive heart failure, unstable angina, recent myocardial infarction, untreated arrhythmias, or use of anti-arrhythmic therapy excluding beta blockers
- History of myelodysplastic syndrome or acute myeloid leukemia
- Other cancer within 3 years except treated basal or squamous skin cancer and low-risk malignancies
- Uncontrolled infections of grade greater than 2
- Seizure disorder requiring medication
- Known hypersensitivity to study drugs or excipients
- History of allogeneic bone marrow or organ transplant
- Any condition interfering with study participation or safety data interpretation
- Use of strong CYP3A4 enzyme inducers or inhibitors
- Use of P-glycoprotein inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
SCRI - Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, United States, 85711
Actively Recruiting
3
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
4
Providence St. Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
5
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States, 90095
Actively Recruiting
6
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
7
SCRI - Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
8
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
12
SCRI - Maryland Oncology Hematology, P.A.
Annapolis, Maryland, United States, 21401
Actively Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
SCRI - Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
15
University of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
16
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Washington University
St Louis, Missouri, United States, 63108
Actively Recruiting
18
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
19
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
20
The James Cancer Hospital and Solove Research Institute - Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
21
Stephenson Cancer Center at the University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
22
SCRI - Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Actively Recruiting
23
SCRI - Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4238
Actively Recruiting
25
SCRI - Texas Oncology
Fort Worth, Texas, United States, 76104
Actively Recruiting
26
SCRI - Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
27
Monash Medical Centre
Clayton, Melbourne, Australia, VIC 3168
Actively Recruiting
28
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
29
Icon Cancer Centre Chermside
Chermside, Queensland, Australia, QLD 4032
Actively Recruiting
30
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
31
Linear Clinical Research
Perth, Western Australia, Australia, WA 6009
Actively Recruiting
32
Medizinische Universitat Landeskrankenhaus Graz
Graz, Styria, Austria, 8036
Actively Recruiting
33
Universitatsklinik Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
34
Ordensklinikum Linz
Linz, Upper Austria, Austria, 4010
Actively Recruiting
35
Antwerp University Hospital (UZA)
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
36
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
Actively Recruiting
37
UZ Leuven
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
38
CHU Liège
Liège, Wallonia, Belgium, B-4000
Actively Recruiting
39
BC Cancer - Abbotsford
Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
Actively Recruiting
40
British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
41
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
42
Princess Margaret Cancer Centre - University Health Network (UHN)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
43
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
44
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C2
Actively Recruiting
45
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
46
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
47
Centre Leon Berard
Lyon, Auvergne- Rhôn-Alpes, France, 69008
Actively Recruiting
48
Institut de Cancérologie de l'Ouest
Saint-Herblain, Pays de la Loire Region, France, 44805
Actively Recruiting
49
Institut Gustave Roussy
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
50
Universitatsklinikum Heidelberg
Heidelberg, Baden-Wurttenberg, Germany, 69120
Actively Recruiting
51
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
52
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
53
Start Dublin - Mater Misericordiae University Hospital
Dublin, Leinster, Ireland, D07 R2WY
Actively Recruiting
54
St. James Hospital
Dublin, Leinster, Ireland, DO8C9X2
Actively Recruiting
55
IRCCS Giovani Paolo II - Instituto Oncologico
Bari, Apulia, Italy, 70124
Actively Recruiting
56
Humanitas San Pio X
Milan, Milano, Italy, 20159
Actively Recruiting
57
Nuovo Ospedale di Prato S Stefano
Prato, Prato, Italy, 59100
Actively Recruiting
58
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Rome, Italy, 00168
Actively Recruiting
59
National University Cancer Institute
Singapore, Singapore, Singapore, 119074
Actively Recruiting
60
National Cancer Centre
Singapore, Singapore, Singapore, 168583
Actively Recruiting
61
Curie Oncology (Farrer)
Singapore, Singapore, Singapore, 217562
Actively Recruiting
62
Seoul National University Hospital
Seoul, Gwanak-gu, South Korea, 03080
Actively Recruiting
63
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho-Gu, South Korea, 06591
Actively Recruiting
64
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-Gu, South Korea, 03722
Actively Recruiting
65
Asan Medical Center
Seoul, Songpa-Gu, South Korea, 05505
Actively Recruiting
66
Institut Catalá d'Oncologia de Girona
Girona, Catalonia, Spain, 17007
Actively Recruiting
Research Team
H
Hatem Dokainish, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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