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Study of Azenosertib and Niraparib for Patients with Platinum-Resistant Ovarian Cancer

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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 known as Platinum-Resistant Ovarian Cancer. This condition refers to ovarian cancer that does not respond well to treatments containing platinum, a common component in chemotherapy. The study is investigating a new treatment approach using a medication called Azenosertib, which is also known by its code names ZN-c3 and KP-2638. This medication is being tested both on its own and in combination with another drug called Niraparib, which is already used in treating certain types of ovarian cancer.

The purpose of the study is to explore the safety and effectiveness of these treatments. Participants will receive the medications in the form of film-coated tablets taken orally. The study is divided into two phases. In the first phase, the focus is on determining the safe dosage levels of ZN-c3 when used with Niraparib. The second phase aims to assess how well these treatments work in reducing the cancer. The study will also look at the effects of ZN-c3 when used alone, examining both its safety and its ability to fight the cancer.

Throughout the study, participants will be monitored for any side effects and the overall impact of the treatment on their cancer. The study will help researchers understand the potential benefits and risks of using ZN-c3 and Niraparib together or ZN-c3 alone in treating Platinum-Resistant Ovarian Cancer. This research is important for developing new treatment options for patients with this challenging form of cancer.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A sample of the tumor is required, which has been preserved from previous medical procedures.

  2. Step 2

    Medication administration

    The study involves taking two medications: azenosertib and niraparib. Both are taken orally in the form of film-coated tablets.

    The dosage and frequency of these medications will be determined by the study team based on individual health needs and the phase of the trial.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

    Participants are required to report any side effects or changes in health to the study team promptly.

  4. Step 4

    Evaluation of response

    The response to the treatment is evaluated using specific criteria to measure any changes in the cancer.

    This evaluation helps determine the effectiveness of the treatment and any necessary adjustments to the medication regimen.

  5. Step 5

    Completion of trial

    Upon completion of the trial, a final assessment is conducted to evaluate overall health and the impact of the treatment.

    Participants may be asked to continue follow-up visits to monitor long-term effects.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of recurrent high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer. This includes specific types like serous, clear cell, or endometrioid cancer.
  • Your cancer must be platinum-resistant, meaning it does not respond to treatments that contain platinum.
  • You must have a tumor that can be measured or evaluated according to specific medical guidelines (RECIST v1.1).
  • You need to have adequate blood and organ function, which will be assessed by your doctor.
  • You must be able and willing to take medication by mouth.
  • You need to provide a sample of your tumor, which has been preserved in a specific way (formalin-fixed, paraffin-embedded).
  • You must be female.
  • You must be within the age range specified for the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have Platinum-Resistant Ovarian Cancer cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are not within the specified age range cannot participate. (The specific age range is not provided here.)
  • Patients who are part of a vulnerable population may not be eligible. This typically includes groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

  • ZN-c3

    is a medication being studied to see how safe it is and how well it works against cancer. In this trial, it is being tested both by itself and in combination with another medication. The goal is to find out if it can help treat ovarian cancer that has not responded to other treatments. Researchers are looking at how the body handles the medication and if it can shrink or slow down the growth of cancer.

  • Niraparib

    is a medication that is already used to treat certain types of ovarian cancer. It works by blocking a specific protein in cancer cells, which can help stop the cancer from growing. In this trial, it is being used together with ZN-c3 to see if the combination is more effective than using either medication alone. The study aims to find out if this combination can provide better results for patients with ovarian cancer that has not responded to other treatments.

What is already known about the treatment

  • ZN-c3

    ZN-c3 is administered orally and is currently being studied in clinical trials for its potential use in treating platinum-resistant ovarian cancer. It is in the early stages of research, with ongoing studies to determine its safety, tolerability, and effectiveness. The main therapeutic indication for ZN-c3 is its potential to treat ovarian cancer that does not respond to platinum-based chemotherapy. At the molecular level, ZN-c3 works by inhibiting certain enzymes that are involved in cancer cell growth, which may help to slow down or stop the progression of the disease. It is classified as an investigational drug, meaning it is still under study and not yet approved for general medical use.

  • Niraparib

    Niraparib is an oral medication that is already approved for use in treating certain types of ovarian cancer, including those that are resistant to platinum-based treatments. It is well-documented in medical literature and is used primarily to help maintain remission in patients who have responded to initial chemotherapy. Niraparib works by blocking a specific enzyme involved in DNA repair, which can lead to the death of cancer cells. It is classified as a PARP inhibitor, a type of drug that targets cancer cells with specific genetic mutations.

Investigated diseases

Platinum-Resistant Ovarian Cancer – Platinum-resistant ovarian cancer is a type of ovarian cancer that does not respond to platinum-based chemotherapy treatments. This form of cancer typically progresses despite treatment, as the cancer cells have developed resistance to the drugs. The disease often involves the growth and spread of malignant cells in the ovaries, which can lead to the formation of tumors. As the cancer progresses, it may spread to other parts of the body, including the abdomen and pelvis. Symptoms can include abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary, but it generally involves a decrease in the effectiveness of standard chemotherapy treatments over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515196-35-00Protocol codeZN-c3-006Estimated enrolment345 patientsSponsorK-Group Beta Inc.

sourced from the EU Clinical Trials Register and site verification

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