Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma

This research study is for adult women who have a specific type of womb cancer known as uterine serous carcinoma. This is when the cancer has returned or hasn't gone away after previous treatments. The study is testing a new medicine called ZN-c3. Researchers want to find out how safe ZN-c3 is and how well it works to shrink the cancer or stop it from growing. They will also look at any side effects people might experience. This is a Phase 2 study, which means it builds on earlier research and aims to get more information about the medicine's effects in people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

K-Group Beta Inc.

Enrolment target

Start

26 Mar 2024

recurrent or persistent uterine serous carcinoma

What is this study about?

This study is investigating a new treatment called ZN-c3 for women diagnosed with uterine serous carcinoma. This is a specific kind of womb cancer. The study is particularly for those whose cancer has returned after previous treatments (recurrent) or has not fully gone away (persistent).

The main goals of this study are to understand two key things about ZN-c3: first, how safe it is and what side effects people might experience. This involves carefully tracking any unwanted reactions. Second, the researchers want to see how effective ZN-c3 is at treating the cancer, for example, if it can make tumours smaller or stop them from growing. This involves regular checks to monitor the cancer's response.

By participating, you would help doctors learn more about this potential new medicine. This information is crucial for understanding whether ZN-c3 could be a helpful treatment option for women with this type of cancer in the future. The study will also look at other important details like how long the treatment benefits last and how the medicine moves through the body.

Key takeaways

This study is for adult women with a specific type of womb cancer.
It's testing a new medicine called ZN-c3.
The main goals are to check safety and how well it treats the cancer.
You will have regular visits and monitoring.
Participation helps future patients and may offer a new treatment option.

Who may be eligible?

This study is designed specifically for adult women. You must be at least 18 years old to be considered for participation. There is no upper age limit mentioned.

To be eligible, you must have been diagnosed with uterine serous carcinoma. This means a type of cancer that starts in the lining of the womb.

Importantly, your cancer must either have come back after previous treatment (recurrent) or still be present despite earlier treatments (persistent).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman?
Are you aged 18 years or older?
Do you have uterine serous carcinoma?
Has your cancer come back or is it still present after previous treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine called ZN-c3. You might also receive other common medicines that help with side effects like nausea and vomiting, such as aprepitant, granisetron, dexamethasone, Akynzeo, or ondansetron, and olanzapine.

The study involves regular visits to the clinic so the medical team can monitor your health and how the medicine is affecting you. These visits would include things like blood tests, physical examinations, and scans to see how the cancer is responding. The doctors will also carefully record any side effects you might experience.

The total duration of your participation would depend on how your body responds to the treatment and other factors, but you would be monitored throughout the treatment period and potentially for a follow-up period afterwards.

Potential risks and benefits

Participating in a study like this offers the potential benefit of accessing a new treatment (ZN-c3) before it's widely available. It also helps advance medical knowledge for others with similar conditions. However, like all medicines, ZN-c3 may cause side effects, some of which could be serious. The medical team will monitor you closely for any unwanted effects. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy
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Unverified
France

Common questions

What kind of cancer is uterine serous carcinoma?

It's a specific type of cancer that starts in the lining of the womb (uterus).

What does 'recurrent or persistent' mean?

It means the cancer has either come back after past treatments or is still present even after you've had treatment.

What is ZN-c3?

ZN-c3 is a new medicine being tested in this study to see if it can help treat this type of cancer.

Will I have to take other medicines too?

Yes, you might receive other common medicines to help prevent or manage side effects like feeling sick.

How long will I be in the study?

The length of time you participate will depend on how your treatment is going and what the doctors decide is best for you.