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Study on the Effects of ZN-c3 for Patients with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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 clinical trial is focused on studying the effectiveness and safety of a medication called azenosertib, also known by its code name ZN-c3. The study is specifically for patients with a type of cancer known as High-Grade Serous Ovarian Cancer, which can also affect the fallopian tubes or the lining of the abdomen, known as the peritoneum. The purpose of the study is to evaluate how well ZN-c3 works in treating this cancer and to understand any side effects it may cause.

Participants in the study will receive ZN-c3 in the form of film-coated tablets taken orally. The study will be conducted in two parts. In the first part, the focus will be on determining the safety and how well patients can tolerate ZN-c3. The second part will investigate the medication's ability to reduce or eliminate the cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of ZN-c3.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants' health and the cancer's response to the treatment. The goal is to gather information that could lead to better treatment options for patients with this type of cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of cancer, and previous treatments.

    The study focuses on individuals with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and ensure all eligibility criteria are met.

    This includes confirming the presence of measurable lesions and assessing overall health and organ function.

  3. Step 3

    Treatment phase 1b

    The first part of the treatment involves taking azenosertib (also known as ZN-c3) orally.

    The main goal is to determine the safety and tolerability of the medication.

  4. Step 4

    Monitoring and adjustments

    Regular monitoring is conducted to observe any side effects or adverse events.

    Adjustments to the dosage may be made based on individual tolerance and response.

  5. Step 5

    Treatment phase 2

    In the second phase, the focus shifts to evaluating the antitumor activity of azenosertib.

    The objective response rate is assessed to determine the effectiveness of the treatment.

  6. Step 6

    Ongoing evaluation

    Throughout the study, ongoing evaluations are conducted to measure response duration, progression-free survival, and overall survival.

    These assessments help in understanding the long-term benefits and risks of the treatment.

  7. Step 7

    Completion of study

    The study is estimated to conclude by September 2027.

    Final assessments are made to gather comprehensive data on the treatment's efficacy and safety.

Who can join the trial?

6 criteria

  • Must be at least 18 years old at the time of giving consent to participate.
  • Must have a confirmed diagnosis of **recurrent high-grade serous ovarian, fallopian tube, or primary peritoneal cancer**. This means the cancer has come back after treatment and is of a specific type.
  • Must have **platinum-resistant disease**, meaning the cancer does not respond well to platinum-based chemotherapy. You can have had one to four previous treatments, or up to five in some cases.
  • Must have at least one **measurable lesion**. This means there is a tumor that can be measured to see if it changes in size during the study.
  • Must have a **Performance Status** score of 0 or 1 according to the **Eastern Cooperative Oncology Group (ECOG)**. This score indicates how well you can carry out daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • Must have **adequate hematologic and organ function**. This means your blood and organs are working well enough to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than the specific ones being studied, which are **High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer**.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population that the study is not designed to include.
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Investigated drugs

ZN-c3 is an investigational medication being studied for its potential to treat certain types of cancer, specifically high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. The trial aims to evaluate how safe and tolerable this medication is for patients, as well as its effectiveness in reducing or controlling the growth of tumors in these types of cancer.

What is already known about the treatment

ZN-c3 – ZN-c3 is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. It is in the investigational stage, with ongoing research to determine its potential benefits and risks. The main therapeutic indication for ZN-c3 is its use in patients with these specific types of cancer. At the molecular level, ZN-c3 works by inhibiting certain enzymes that are involved in cancer cell growth and survival, potentially slowing down or stopping the progression of the disease. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer – This is a type of cancer that originates in the cells lining the ovaries, fallopian tubes, or the peritoneum, which is the tissue lining the abdominal wall and covering abdominal organs. It is characterized by the rapid growth of abnormal cells that can spread to other parts of the body. The disease often presents with vague symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits, which can lead to a delay in diagnosis. As the cancer progresses, it may cause more noticeable symptoms and can spread to nearby organs and tissues. The high-grade serous subtype is known for its aggressive nature and tendency to be diagnosed at an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502983-19-00Protocol codeZN‑c3-005Estimated enrolment253 patientsSponsorK-Group Beta Inc.

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