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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06690775




Registration number
NCT06690775
Ethics application status
Date submitted
13/11/2024
Date registered
15/11/2024
Date last updated
26/06/2025

Titles & IDs
Public title
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Scientific 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
Secondary ID [1] 0 0
2024-517190-24-00
Secondary ID [2] 0 0
TORL123-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Primary Peritoneal 0 0
Fallopian Tube Cancer 0 0
Endometrioid Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TORL-1-23
Treatment: Drugs - TORL-1-23
Treatment: Drugs - TORL-1-23
Treatment: Drugs - Pegfilgrastim (drug)

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.

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.

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.


Treatment: Drugs: TORL-1-23
2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: TORL-1-23
3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: TORL-1-23
3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: Pegfilgrastim (drug)
6.0 mg subcutaneous injection on Day 4 of each cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6
Assessment method [1] 0 0
Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Assessment method [1] 0 0
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and investigator assessment
Timepoint [1] 0 0
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Assessment method [2] 0 0
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by investigator assessment
Timepoint [2] 0 0
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Assessment method [3] 0 0
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and by investigator assessment
Timepoint [3] 0 0
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Assessment method [4] 0 0
To assess additional efficacy outcome measures of TORL-1-23
Timepoint [4] 0 0
From time of consent until death or completion of study (Study duration is approximately 40 months)
Secondary outcome [5] 0 0
Incidence and severity of AEs and clinical laboratory abnormalities per CTCAE v5.0
Assessment method [5] 0 0
To assess the safety and tolerability of TORL-1-23
Timepoint [5] 0 0
From informed consent until 30 days after the last dose of study treatment, approximately 24 months (each cycle is 21 days)
Secondary outcome [6] 0 0
CA-125 response per Gynecological Cancer Intergroup (GCIG) criteria
Assessment method [6] 0 0
To assess the pharmacodynamic effects of TORL-1-23
Timepoint [6] 0 0
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneQLD,WA
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Icon Cancer Centre Chermside - Chermside
Recruitment hospital [3] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [2] 0 0
QLD 4032 - Chermside
Recruitment postcode(s) [3] 0 0
WA 6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TORL Biotherapeutics, LLC
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hatem Dokainish, PhD
Address 0 0
Country 0 0
Phone 0 0
310-348-9636
Email 0 0
CATALINA-2-Study@torlbio.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.