Study of TORL-1-23 and pegfilgrastim in women with advanced platinum-resistant ovarian, peritoneal, or fallopian tube cancer expressing CLDN6

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What is this study about?

This study focuses on women with advanced forms of ovarian cancer, peritoneal cancer, and fallopian tube cancer that have become resistant to platinum-based treatments. The research examines a new medication called TORL-1-23, which is a specialized antibody drug that targets a specific protein called CLDN6 found in these cancers. The purpose is to evaluate how well TORL-1-23 works and how safe it is when used alone in treating these types of cancer.

The treatment involves receiving TORL-1-23 through an intravenous infusion (given directly into a vein). During the study, participants may also receive pegfilgrastim, a supportive medication that helps the body produce white blood cells after treatment. The study treatment may continue for up to 24 months, depending on how well participants respond to the therapy.

The study medication TORL-1-23 is designed to specifically target cancer cells that have the CLDN6 protein on their surface. It works by delivering a cancer-fighting substance directly to these cells while aiming to minimize effects on healthy cells. This targeted approach represents a new way of treating these types of cancer that no longer respond to standard platinum-based treatments.

1 Initial medical evaluation

You will undergo evaluation to confirm diagnosis of advanced or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has not responded to previous platinum-based treatment.

Your tumor tissue will be tested for CLDN6 expression in a specialized laboratory to determine if you are eligible for the treatment.

2 Baseline measurements

Your tumor will be measured to establish a starting point for tracking treatment progress.

Medical imaging will be performed to document the current state of measurable tumors.

3 Treatment administration

You will receive TORL-1-23 through intravenous infusion (delivery of medication directly into your vein).

The medication contains a specialized antibody that targets specific proteins (CLDN6) on cancer cells.

4 Ongoing monitoring

Regular imaging scans will be performed to evaluate how your tumors respond to treatment.

Response to treatment will be assessed using standardized criteria (RECIST version 1.1) by independent medical experts.

The study will continue until July 2028.

5 Treatment response evaluation

Your response to treatment will be classified as either complete response (tumors disappear), partial response (tumors shrink), stable disease, or progressive disease.

These evaluations will help determine the effectiveness of TORL-1-23 in treating your type of cancer.

Who Can Join the Study?

  • Must be female and at least 18 years old
  • Must have a confirmed diagnosis of one of these cancers that cannot be surgically removed (unresectable) or has spread to other parts of the body (metastatic):
    • High-grade serious ovarian cancer
    • Primary peritoneal cancer (cancer that starts in the lining of the abdomen)
    • Fallopian tube cancer
  • Must have cancer that does not respond to treatments containing platinum (a type of chemotherapy drug)
  • The tumor must show positive results for CLDN6 (a specific protein) when tested in an approved laboratory
  • Must have a tumor that can be measured by medical imaging tests

Who Cannot Join the Study?

  • Male patients (study is only for female participants)
  • Patients under 18 years of age
  • Patients who do not have CLDN6 expression (a specific protein marker) in their cancer
  • Patients who do not have one of these cancers: peritoneal cancer (cancer of the tissue lining the abdomen), ovarian cancer, or fallopian tube cancer
  • Patients from vulnerable populations (such as those unable to give informed consent)
  • Patients who are participating in other clinical trials
  • Patients who have not been diagnosed with advanced or recurrent cancer
  • Patients who have had previous treatment with TORL-1-23 (the study medication)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fakultni Nemocnice Bulovka Prague Czechia
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Hospital Galway Galway Ireland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Jessa Ziekenhuis Hasselt Belgium
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Azienda USL Toscana Centro Prato Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
University Hospital Ostrava Ostrava Czechia
Hpbloidmn Mongybpy Skewsw Milan Italy
Cyciiu Lglt Bvbakk Lyon France
Urukqwlkit Mkeydyu Cgkcob Howumbxoyczuxmztv Hamburg Germany
Osborrdneiioum Lljt Gttd Linz Austria
Cbyk Unzczokgbi Hzzmblrd Cork Ireland
Ihroipri Cqcrbg Dldeznlhwmglyynuc L'hospitalet De Llobregat Spain
Cveaiivmk Utbxyxxuipzvut Sspxjfiog Woluwe-Saint-Lambert Belgium
Uvwxxrshgs Ow Axfipzs Edegem Belgium
Htqskayo Vsqr drzkgsfh Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
16.09.2025
Belgium Belgium
Recruiting
16.09.2025
Czechia Czechia
Recruiting
16.09.2025
France France
Recruiting
16.09.2025
Germany Germany
Recruiting
16.09.2025
Ireland Ireland
Recruiting
16.09.2025
Italy Italy
Recruiting
16.09.2025
Spain Spain
Recruiting
16.09.2025

Trial locations

TORL-1-23 is an investigational therapy being studied for the treatment of advanced ovarian cancer, including cancers of the fallopian tubes and peritoneum (the lining of the abdominal cavity). This medication targets a specific protein called Claudin 6 (CLDN6) that is found in certain types of ovarian cancer cells. It is being tested as a single therapy in women whose cancer has become resistant to platinum-based chemotherapy treatments.

Peritoneal Cancer – A condition where cancerous cells develop in the peritoneum, the thin layer of tissue that lines the inside of the abdomen and covers most abdominal organs. The cancer can form as small nodules or masses throughout the peritoneal cavity. This type of cancer can spread across the peritoneal surfaces and affect multiple organs within the abdominal cavity.

Ovarian Cancer – A disease in which abnormal cells develop in the ovaries, the female reproductive organs that produce eggs. The cancer typically begins in the outer layer of the ovaries. As it progresses, cancer cells can spread within the pelvis and abdomen. The disease often develops without noticeable early symptoms.

Fallopian Tube Cancer – A rare cancer that develops in the fallopian tubes, the structures that connect the ovaries to the uterus. The cancer begins in the cells lining the fallopian tubes. As the disease advances, abnormal cells multiply and can spread to nearby structures. This cancer shares many similarities with ovarian cancer in terms of its behavior and progression.

Trial ID:
2024-517190-24-00
Protocol code:
TORL123-002
NCT ID:
NCT06690775
Trial Phase:
Therapeutic exploratory (Phase II)

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