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Study of Azenosertib (ZN-c3) for Women with Recurrent or Persistent Uterine Serous Carcinoma

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called uterine serous carcinoma, which is a form of endometrial cancer that can be difficult to treat when it comes back or doesn't go away. The study is testing a new treatment called azenosertib, also known by its code name ZN-c3. This medication is being evaluated to see how safe it is and how well it works in treating this specific type of cancer.

The trial will involve taking the medication in the form of a film-coated tablet. Participants will be monitored to understand how their bodies respond to the treatment and to check for any side effects. The study aims to gather information on the medication's ability to reduce or control the cancer and to assess its overall safety for patients.

Throughout the study, participants will receive regular check-ups and tests to track their progress. The goal is to determine if ZN-c3 can be a beneficial treatment option for women with recurrent or persistent uterine serous carcinoma, providing new hope for those who have limited treatment options. The study will also compare the effects of ZN-c3 with other treatments, including a placebo, to ensure comprehensive results.

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

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of azenosertib, also known as ZN-c3. This medication is taken orally in the form of a hard capsule.

    The primary goal at this stage is to assess the safety and tolerability of ZN-c3 in individuals with recurrent or persistent uterine serous carcinoma.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to evaluate the frequency and severity of any side effects, known as treatment-emergent adverse events (TEAEs).

    Laboratory tests are performed to check for any abnormalities, and adjustments to the dosage may be made if necessary.

  3. Step 3

    Evaluation of treatment effectiveness

    The effectiveness of ZN-c3 is assessed by measuring the overall response rate (ORR) using specific criteria known as RECIST v1.1.

    This involves determining the reduction in tumor size or the complete disappearance of the tumor.

  4. Step 4

    Continuation of treatment

    If the treatment is well-tolerated and shows signs of effectiveness, it continues as planned.

    The duration of the treatment is determined by the study protocol and the individual's response to the medication.

  5. Step 5

    Final assessment and conclusion

    At the end of the study, a comprehensive assessment is conducted to evaluate the overall outcomes of the treatment.

    The study aims to conclude by May 31, 2025, with all data collected and analyzed to determine the potential benefits and risks of ZN-c3 for future use.

Who can join the trial?

15 criteria

  • You must provide signed informed consent before starting any study-related procedures.
  • You must be a female who is 18 years old or older.
  • You must have a confirmed diagnosis of **recurrent or persistent uterine serous carcinoma (USC)**, which means the cancer has come back or continues to exist. There should be no other proven effective treatment options available, or you did not tolerate or refused any available standard treatment. If you have endometrial carcinoma with mixed histology, the serous component must be at least 5% of the tumor. **Carcinosarcomas** are not eligible.
  • Your **ECOG Performance Status (PS)** must be 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
  • You must have measurable disease according to **RECIST 1.1 criteria**, which means the cancer can be measured by scans or physical exams, and it has not been previously treated with radiation or has progressed after radiation therapy.
  • You must have had prior therapy for endometrial cancer, including a **platinum-based chemotherapy regimen** and a **PD-(L)1 inhibitor**, unless you are not eligible or it is unavailable in your region. If you have known **HER2-positive tumors**, you must have had at least one **HER2-targeted therapy**, unless you are not eligible or it is unavailable in your region.
  • You must provide a **FFPE tumor tissue block** collected within 3 years before giving informed consent.
  • You must have adequate blood and organ function during the screening period, including:
    • **ANC** (a type of white blood cell) of at least 1.5 x 109/L
    • **Hemoglobin (Hgb)** of at least 9.0 g/dL without a blood transfusion in the prior 14 days
    • **Platelet count** of at least 100 x 109/L
    • **ALT** and **AST** (liver enzymes) levels not more than 3 times the upper limit of normal (ULN), or not more than 5 times ULN if due to liver metastases
    • **Total serum bilirubin** not more than 1.5 times ULN, or not more than 3 times ULN in the case of **Gilbert’s Syndrome**
    • **Creatinine clearance (CrCl)** of at least 30 mL/min based on the **Cockcroft-Gault method**
    • If you are a female of childbearing potential, you must agree to use an effective method of contraception before the first dose and for at least 6 months after the last dose of the study drug.
    • You must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate.
  • Patients who do not have **recurrent or persistent uterine serous carcinoma** cannot participate. This is a type of cancer that affects the lining of the uterus and has either come back or continues to exist.
  • Patients who are considered part of a vulnerable population cannot participate. This means individuals who might need special protection or care.
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Investigated drugs

ZN-c3 is a medication being studied for its potential to treat women with recurrent or persistent uterine serous carcinoma, a type of cancer. The trial aims to assess how safe and tolerable this medication is for patients, as well as its ability to reduce or control the tumor.

What is already known about the treatment

ZN-c3 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating recurrent or persistent uterine serous carcinoma. It is in the investigational stage, meaning it is not yet approved for general medical use but is being evaluated in research settings. The main therapeutic indication for ZN-c3 is to treat this specific type of uterine cancer. At the molecular level, ZN-c3 works by inhibiting certain enzymes that are involved in cancer cell growth, thereby potentially slowing down or stopping the progression of the disease. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

Uterine Serous Carcinoma – Uterine serous carcinoma is a type of endometrial cancer that originates in the lining of the uterus. It is known for its aggressive nature and tendency to spread quickly beyond the uterus. This cancer is characterized by the presence of serous cells, which are a type of epithelial cell. It often presents in postmenopausal women and can be associated with genetic mutations. The disease may recur or persist even after initial treatment, making it challenging to manage. Progression involves the potential spread to other parts of the body, including the lymph nodes and abdominal cavity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507324-23-00Protocol codeZN‑c3-004Estimated enrolment120 patientsSponsorK-Group Beta Inc.

sourced from the EU Clinical Trials Register and site verification

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