Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors

This study is testing a new medicine called Debio 0123. It’s for adults who have advanced solid tumours, which means cancers that have spread. The main goals are to see if the medicine is safe to use and if it shows any signs of helping to reduce or control the cancer. This is a very early stage of research, often called a Phase 1 study, where doctors are still learning a lot about the new treatment. It involves different groups of people, including those with specific types of ovarian cancer, uterine cancer, or other tumours that have certain genetic features. The study aims to gather important information that could lead to new treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Debiopharm International S.A.

Enrolment target

Start

21 Feb 2024

Arm A: Diagnosed with uterine serous carcinoma (USC) Arm B: Diagnosed with recurrent or progressive high-grade epithelial ovarian cancer (EOC) with cyclin E1-driven selection Arm C: Diagnosed with solid tumor with biomarker-driven selection

What is this study about?

This study is about a new medicine called Debio 0123. Researchers want to find out two main things: first, is it safe for people, and second, does it show any early signs that it can help treat advanced solid tumours? Advanced solid tumours are cancers that have grown in specific organs and may have spread to other parts of the body. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

There are different groups of people who might take part in this study, depending on their type of cancer. For example, some participants might have a specific kind of uterine cancer called uterine serous carcinoma (USC). Others might have a type of ovarian cancer that has come back or gotten worse, especially if their cancer has a particular feature called 'cyclin E1-driven selection'. There's also a group for people with other solid tumours where the cancer cells have a specific genetic marker that the new drug is designed to target.

The idea behind this research is to see if Debio 0123 can be a helpful new treatment option in the future for people with these difficult-to-treat cancers. By carefully checking its safety and any early effects on tumours, doctors can decide if it's worth continuing to study this medicine in larger groups of people.

Key takeaways

This is an early-stage clinical trial for a new cancer medicine.
The study drug is called Debio 0123.
It's for adults with specific types of advanced solid tumours.
Primary goals are to assess safety and early signs of anti-tumour activity.
Participation involves regular medical assessments and receiving the study drug.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with advanced solid tumours. This means your cancer has spread or is difficult to treat with standard therapies. Your doctor will need to confirm if your specific cancer type fits the study criteria.

Specifically, the study is looking for people with particular types of cancer. This includes uterine serous carcinoma, or a type of ovarian cancer that has returned or progressed and has a specific genetic feature. Other types of solid tumours are also included if they have certain genetic markers that the new medicine is designed to target.

Your cancer specialist will be able to look at your medical history and test results to see if you meet all the requirements for this study. There will be other health checks to make sure taking part is safe for you.

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 18 years old or older?
Do you have an advanced solid tumour?
Has your cancer specialist said you have uterine serous carcinoma, or a specific type of ovarian cancer that has come back?
Or, does your cancer have a particular genetic marker that the new drug targets?
Are you suitable for a new, experimental treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks to monitor your health and the effects of the treatment. This would include physical exams, blood tests, and scans to see how your tumour is responding. You would receive the study medicine, Debio 0123, as outlined by the study doctors. The study aims to monitor your progress over a period, and there would be follow-up appointments even after you stop taking the medicine to ensure your well-being. The exact length of your participation would depend on how your body responds to the treatment and the study plan, but your doctor will explain everything in detail.

Potential risks and benefits

Like all medicines, Debio 0123 might have side effects, which the study doctors will carefully monitor. It's important to remember that because this is an early-stage study, not all risks are known, and there's no guarantee the treatment will help. However, a potential benefit could be that the medicine helps to slow down or shrink your tumour, offering a new treatment option where others may have been less effective. Taking part also helps doctors learn more about cancer, which could help future patients. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is Debio 0123?

It's a new medicine being tested to see if it can help treat advanced solid tumours. This is an early-stage study.

Who can take part in this study?

Adults aged 18 or over with certain types of advanced solid tumours, such as specific uterine or ovarian cancers, or other cancers with particular genetic features.

What are 'advanced solid tumours'?

These are cancers that started in organs and may have spread. They are often cancers that are difficult to treat with standard therapies.

Will this medicine cure my cancer?

This is an early-stage study to check safety and if the medicine shows any signs of helping. There's no guarantee of a cure.

What does 'monotherapy' mean?

It means you'd be receiving Debio 0123 on its own, not in combination with other anti-cancer treatments.