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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

8 criteria

  • 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)
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Investigated drugs

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.

What is already known about the treatment

TORL-1-23 – An investigational drug being studied in clinical trials for the treatment of advanced platinum-resistant epithelial ovarian cancer, peritoneal cancer, and fallopian tube cancer that express Claudin 6 (CLDN6) protein. The medication is being evaluated as a monotherapy, though its specific form of administration is not detailed in the available trial information. This novel therapeutic agent represents a targeted approach in gynecologic oncology, specifically focusing on cancers that express the CLDN6 biomarker. While still in Phase 2 clinical trials, TORL-1-23 is being investigated for its efficacy and safety in treating patients who have developed resistance to platinum-based therapies, which represents a significant unmet medical need in ovarian cancer treatment.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517190-24-00Protocol codeTORL123-002Estimated enrolment235 patientsSponsorTorl Biotherapeutics LLC

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