RecruitingPhase 2NCT06690775

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

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

Sponsor

TORL Biotherapeutics, LLC

Enrollment

230 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Endometrioid Ovarian Cancer Fallopian Tube Cancer Epithelial Ovarian Cancer Primary Peritoneal

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (CATALINA-2) is testing a new drug called TORL-1-23 for women with platinum-resistant ovarian cancer — meaning the cancer continued to grow during or shortly after platinum-based chemotherapy. The drug is designed to target ovarian cancer cells in a new way. **You may be eligible if...** - You are female, 18 or older - You have confirmed ovarian, fallopian tube, or peritoneal cancer (epithelial type) - Your cancer has progressed during or within 6 months of completing platinum-based chemotherapy (platinum-resistant) - You have received prior standard therapies **You may NOT be eligible if...** - Your cancer is not the platinum-resistant epithelial type - You have cancer that has spread to the brain - You have significant heart, liver, or other organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTORL-1-23

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

DRUGTORL-1-23

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

DRUGTORL-1-23

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

DRUGPegfilgrastim (drug)

6.0 mg subcutaneous injection on Day 4 of each cycle.

Locations(66)

Mayo Clinic Hospital

Phoenix, Arizona, United States

SCRI - Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

Providence St. Jude Medical Center

Fullerton, California, United States

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

SCRI - Sansum Clinic

Santa Barbara, California, United States

Smilow Cancer Hospital at Yale - New Haven

New Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

SCRI - Maryland Oncology Hematology, P.A.

Annapolis, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

SCRI - Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Duke Cancer Center

Durham, North Carolina, United States

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

Columbus, Ohio, United States

Stephenson Cancer Center at the University of Oklahoma

Oklahoma City, Oklahoma, United States

SCRI - Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

SCRI - Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

SCRI - Texas Oncology

Fort Worth, Texas, United States

SCRI - Virginia Oncology Associates

Norfolk, Virginia, United States

Monash Medical Centre

Clayton, Melbourne, Australia

Blacktown Hospital

Blacktown, New South Wales, Australia

Icon Cancer Centre Chermside

Chermside, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Medizinische Universitat Landeskrankenhaus Graz

Graz, Styria, Austria

Universitatsklinik Innsbruck

Innsbruck, Tyrol, Austria

Ordensklinikum Linz

Linz, Upper Austria, Austria

Antwerp University Hospital (UZA)

Edegem, Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, Belgium

UZ Leuven

Leuven, Flemish Brabant, Belgium

CHU Liège

Liège, Wallonia, Belgium

BC Cancer - Abbotsford

Abbotsford British Columbia, British Columbia, Canada

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

Vancouver, British Columbia, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre - University Health Network (UHN)

Toronto, Ontario, Canada

Hospital Maisonneuve Rosemont

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, Canada

Centre Leon Berard

Lyon, Auvergne- Rhôn-Alpes, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Universitatsklinikum Heidelberg

Heidelberg, Baden-Wurttenberg, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Start Dublin - Mater Misericordiae University Hospital

Dublin, Leinster, Ireland

St. James Hospital

Dublin, Leinster, Ireland

IRCCS Giovani Paolo II - Instituto Oncologico

Bari, Apulia, Italy

Humanitas San Pio X

Milan, Milano, Italy

Nuovo Ospedale di Prato S Stefano

Prato, Prato, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Rome, Italy

National University Cancer Institute

Singapore, Singapore, Singapore

National Cancer Centre

Singapore, Singapore, Singapore

Curie Oncology (Farrer)

Singapore, Singapore, Singapore

Seoul National University Hospital

Seoul, Gwanak-gu, South Korea

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

Seoul, Seocho-Gu, South Korea

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-Gu, South Korea

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Institut Catalá d'Oncologia de Girona

Girona, Catalonia, Spain

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