New hope for hard-to-treat ovarian cancer: targeted drug enters phase 2 trial

NCT ID NCT06690775

Disease control Sponsor: TORL Biotherapeutics, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called TORL-1-23 in women with advanced ovarian cancer that no longer responds to platinum-based chemotherapy. The drug targets a protein called claudin 6 found on cancer cells. About 230 women will receive the drug to see if it shrinks tumors and how safe it is.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial fallopian tube cancer fallopian tube neoplasm ovarian carcinoma ovarian endometrioid adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrioid ovarian cancer Epithelial ovarian cancer Fallopian tube cancer Primary peritoneal

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

66 sites in 12 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Antwerp University Hospital (UZA)
RECRUITING

Edegem, Antwerp, 2650, Belgium
Asan Medical Center
RECRUITING

Seoul, Songpa-Gu, 05505, South Korea
BC Cancer - Abbotsford
RECRUITING

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Blacktown Hospital
RECRUITING

Blacktown, New South Wales, 2148, Australia
British Columbia Cancer Agency (BC Cancer, part of the Provincial Health Services Authority)
RECRUITING

Vancouver, British Columbia, V5Z 4E6, Canada
CHU Liège
RECRUITING

Liège, Wallonia, B-4000, Belgium
Centre Hospitalier de l'Universite de Montreal (CHUM)
RECRUITING

Montreal, Quebec, H2X 0C2, Canada
Centre Leon Berard
RECRUITING

Lyon, Auvergne- Rhôn-Alpes, 69008, France
Charité Universitätsmedizin Berlin
RECRUITING

Berlin, State of Berlin, 13353, Germany
City of Hope National Medical Center
RECRUITING

Duarte, California, 91010, United States
Cliniques Universitaires Saint-Luc
RECRUITING

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Curie Oncology (Farrer)
RECRUITING

Singapore, Singapore, 217562, Singapore
Duke Cancer Center
RECRUITING

Durham, North Carolina, 27710, United States
Flinders Medical Centre
RECRUITING

Bedford Park, South Australia, 5042, Australia
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING

Rome, Rome, 00168, Italy
Hospital Maisonneuve Rosemont
RECRUITING

Montreal, Quebec, H1T 2M4, Canada
Humanitas San Pio X
RECRUITING

Milan, Milano, 20159, Italy
IRCCS Giovani Paolo II - Instituto Oncologico
RECRUITING

Bari, Apulia, 70124, Italy
Icon Cancer Centre Chermside
RECRUITING

Chermside, Queensland, QLD 4032, Australia
Institut Catalá d'Oncologia de Girona
RECRUITING

Girona, Catalonia, 17007, Spain
Institut Gustave Roussy
RECRUITING

Villejuif, Île-de-France Region, 94805, France
Institut de Cancérologie de l'Ouest
RECRUITING

Saint-Herblain, Pays de la Loire Region, 44805, France
Linear Clinical Research
RECRUITING

Perth, Western Australia, WA 6009, Australia
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic Florida
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic Hospital
RECRUITING

Phoenix, Arizona, 85054, United States
McGill University Health Centre (MUHC) - Royal Victoria Hospital
RECRUITING

Montreal, Quebec, H4A 3J1, Canada
Medizinische Universitat Landeskrankenhaus Graz
RECRUITING

Graz, Styria, 8036, Austria
Monash Medical Centre
RECRUITING

Clayton, Melbourne, VIC 3168, Australia
National Cancer Centre
RECRUITING

Singapore, Singapore, 168583, Singapore
National University Cancer Institute
RECRUITING

Singapore, Singapore, 119074, Singapore
Nuovo Ospedale di Prato S Stefano
RECRUITING

Prato, Prato, 59100, Italy
Ordensklinikum Linz
RECRUITING

Linz, Upper Austria, 4010, Austria
Princess Margaret Cancer Centre - University Health Network (UHN)
RECRUITING

Toronto, Ontario, M5G 2M9, Canada
Providence St. Jude Medical Center
RECRUITING

Fullerton, California, 92835, United States
Rutgers Cancer Institute
RECRUITING

New Brunswick, New Jersey, 08901, United States
SCRI - Alliance Cancer Specialists, PC
RECRUITING

Doylestown, Pennsylvania, 18901, United States
SCRI - Arizona Oncology Associates, PC-HOPE
RECRUITING

Tucson, Arizona, 85711, United States
SCRI - Maryland Oncology Hematology, P.A.
RECRUITING

Annapolis, Maryland, 21401, United States
SCRI - Minnesota Oncology Hematology, P.A.
RECRUITING

Minneapolis, Minnesota, 55404, United States
SCRI - Northwest Cancer Specialists, P.C.
RECRUITING

Portland, Oregon, 97227, United States
SCRI - Sansum Clinic
RECRUITING

Santa Barbara, California, 93105, United States
SCRI - Texas Oncology
RECRUITING

Fort Worth, Texas, 76104, United States
SCRI - Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
Seoul National University Hospital
RECRUITING

Seoul, Gwanak-gu, 03080, South Korea
Sir Mortimer B. Davis Jewish General Hospital
RECRUITING

Montreal, Quebec, H3T 1E2, Canada
Smilow Cancer Hospital at Yale - New Haven
RECRUITING

New Haven, Connecticut, 06510, United States
St. James Hospital
RECRUITING

Dublin, Leinster, DO8C9X2, Ireland
Stanford Cancer Center
RECRUITING

Palo Alto, California, 94304, United States
Start Dublin - Mater Misericordiae University Hospital
RECRUITING

Dublin, Leinster, D07 R2WY, Ireland
Stephenson Cancer Center at the University of Oklahoma
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Sunnybrook Research Institute
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING

Seoul, Seocho-Gu, 06591, South Korea
The James Cancer Hospital and Solove Research Institute - Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
UCLA - JCCC Clinical Research Unit
RECRUITING

Los Angeles, California, 90095, United States
UZ Leuven
RECRUITING

Leuven, Flemish Brabant, 3000, Belgium
Universitatsklinik Innsbruck
RECRUITING

Innsbruck, Tyrol, 6020, Austria
Universitatsklinikum Heidelberg
RECRUITING

Heidelberg, Baden-Wurttenberg, 69120, Germany
University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55404, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104-4238, United States
Universitätsklinikum Erlangen
RECRUITING

Erlangen, Bavaria, 91054, Germany
Washington University
RECRUITING

St Louis, Missouri, 63108, United States
Winship Cancer Institute, Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Yonsei University Health System, Severance Hospital
RECRUITING

Seoul, Seodaemun-Gu, 03722, South Korea

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