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

NCT06690775 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TORL123-0022024-517190-24-00
• Study Type: interventional
• Target: 230
• Locations: 11 countries
• Sites: 61

Brief Summary

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

Conditions

Primary Peritoneal; Fallopian Tube Cancer; Endometrioid Ovarian Cancer; Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

Secondary Outcomes (6)

• Duration of Response (DOR)

  At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

• Objective Response Rate (ORR)

  At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

• Progression-free Survival (PFS)

  At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months

• Overall Survival (OS)

  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

  From informed consent until 30 days after the last dose of study treatment, approximately 24 months (each cycle is 21 days)

Study Arms (3)

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.

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.

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.

Drug: TORL-1-23; Drug: Pegfilgrastim (drug)

Interventions

TORL-1-23 DRUG

2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.

Cohort 1

Pegfilgrastim (drug) DRUG

6.0 mg subcutaneous injection on Day 4 of each cycle.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator
• TORL Biotherapeutics, LLC: lead

Study Sites (66)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

RECRUITING

SCRI - Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, 85711, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

RECRUITING

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

RECRUITING

Stanford Cancer Center

Palo Alto, California, 94304, United States

RECRUITING

SCRI - Sansum Clinic

Santa Barbara, California, 93105, United States

RECRUITING

Smilow Cancer Hospital at Yale - New Haven

New Haven, Connecticut, 06510, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

SCRI - Maryland Oncology Hematology, P.A.

Annapolis, Maryland, 21401, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

SCRI - Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63108, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

The James Cancer Hospital and Solove Research Institute - Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Stephenson Cancer Center at the University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

SCRI - Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227, United States

RECRUITING

SCRI - Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4238, United States

RECRUITING

SCRI - Texas Oncology

Fort Worth, Texas, 76104, United States

RECRUITING

SCRI - Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Monash Medical Centre

Clayton, Melbourne, VIC 3168, Australia

RECRUITING

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

RECRUITING

Icon Cancer Centre Chermside

Chermside, Queensland, QLD 4032, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Linear Clinical Research

Perth, Western Australia, WA 6009, Australia

RECRUITING

Medizinische Universitat Landeskrankenhaus Graz

Graz, Styria, 8036, Austria

RECRUITING

Universitatsklinik Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Ordensklinikum Linz

Linz, Upper Austria, 4010, Austria

RECRUITING

Antwerp University Hospital (UZA)

Edegem, Antwerp, 2650, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

CHU Liège

Liège, Wallonia, B-4000, Belgium

RECRUITING

BC Cancer - Abbotsford

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

RECRUITING

British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre - University Health Network (UHN)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Hospital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0C2, Canada

RECRUITING

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Centre Leon Berard

Lyon, Auvergne- Rhôn-Alpes, 69008, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, 44805, France

RECRUITING

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

RECRUITING

Universitatsklinikum Heidelberg

Heidelberg, Baden-Wurttenberg, 69120, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

Start Dublin - Mater Misericordiae University Hospital

Dublin, Leinster, D07 R2WY, Ireland

RECRUITING

St. James Hospital

Dublin, Leinster, DO8C9X2, Ireland

RECRUITING

IRCCS Giovani Paolo II - Instituto Oncologico

Bari, Apulia, 70124, Italy

RECRUITING

Humanitas San Pio X

Milan, Milano, 20159, Italy

RECRUITING

Nuovo Ospedale di Prato S Stefano

Prato, Prato, 59100, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Rome, 00168, Italy

RECRUITING

National University Cancer Institute

Singapore, Singapore, 119074, Singapore

RECRUITING

National Cancer Centre

Singapore, Singapore, 168583, Singapore

RECRUITING

Curie Oncology (Farrer)

Singapore, Singapore, 217562, Singapore

RECRUITING

Seoul National University Hospital

Seoul, Gwanak-gu, 03080, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-Gu, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa-Gu, 05505, South Korea

RECRUITING

Institut Catalá d'Oncologia de Girona

Girona, Catalonia, 17007, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

pegfilgrastim; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Central Study Contacts

Hatem Dokainish, PhD

CONTACT

310-348-9636; CATALINA-2-Study@torlbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

AU (3); CA (8); IT (4); BE (4); SG (3); ES (1); FR (3); DE (3); KR (4); US (26); IE (2)