AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

PHASE 1/2 STUDY OF PARG INHIBITOR ETX-19477 IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES

This research study is investigating a new drug called ETX-19477. It's for people who have advanced cancer that has continued to grow even after trying standard treatments. The study has two main parts. The first part focuses on finding the safest dose of ETX-19477 and understanding any side effects. The second part then looks at how well the drug works at different doses to shrink tumours or stop their growth. This is a crucial step in developing new cancer treatments, helping scientists understand if this new medicine could be a safe and effective option in the future. Participants' safety and well-being are a top priority throughout the study.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

858 Therapeutics Inc.

Enrolment target

Start

31 Mar 2025

Patients with advanced solid malignancies that have progressed following standard therapy

What is this study about?

This study is a research project looking into a new medicine called ETX-19477. It's designed for people who have advanced cancer that has continued to get worse despite having already received standard treatments. The main goal is to see if this new medicine can help, and to understand how safe it is.

The study is split into two phases. The first phase, called Phase 1, is all about safety. Researchers will give different doses of ETX-19477 to a small number of people to find out what dose is safe and what side effects might happen. They'll also check how the body handles the medicine. Once a safe dose range is established, the study moves to Phase 2.

In Phase 2, researchers will look more closely at how well the medicine works. They'll be checking if it can make tumours smaller or stop them from growing, and how long these effects might last. They will also compare different doses to find the very best dose and schedule for future, larger studies. This step is vital to see if ETX-19477 has the potential to become a useful new treatment for cancer patients.

Key takeaways

This study is testing a new cancer medicine called ETX-19477 for advanced cancers.
It's for people whose cancer has progressed despite standard treatments.
The study first checks for safety and then looks at how well the medicine works.
Participation involves regular check-ups, tests, and taking the study medicine.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria.

Both men and women can take part in this research. The most important requirement is that you have an advanced solid tumour, which means a cancer that started in a specific organ and has spread or is severe, and that your cancer has not responded to or has worsened after receiving the usual available treatments.

Before taking part, a healthcare team will carefully check your medical history and current health to make sure the study is a safe and appropriate option for you. This often involves looking at recent scans, blood tests, and discussing your overall health.

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 (a cancer that started in an organ and has spread/is severe)?
Has your cancer continued to grow or gotten worse after receiving standard treatments?
Are you willing to follow the study schedule and attend appointments?

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, ETX-19477. The exact number of visits and the assessments you'll have will depend on which phase of the study you join and your individual needs. Generally, you would have regular check-ups, which include physical exams, blood tests, and scans to monitor your health and how the medicine is working. Researchers will also closely track any side effects you might experience.

The medication will be given following a specific schedule determined by the study. The total duration of your participation could vary, lasting for several months or even longer, depending on your response to the treatment and the study design. You will be closely supported by the study team throughout your time on the trial. You can expect detailed information about the schedule and procedures during the consent process.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit: you could be among the first to receive a new medicine that could help your specific type of advanced cancer. However, it's important to remember that this is a new drug, and not everyone will benefit. There are also potential risks, as medicines can have side effects. These can range from mild, like tiredness or sickness, to more serious effects that doctors will carefully monitor. During the study, your health will be regularly checked to manage any side effects. You are free 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
France
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Unverified
Italy

Common questions

What is ETX-19477?

ETX-19477 is a new medicine being tested in this study to see if it can treat advanced cancers.

What does 'advanced solid malignancies' mean?

It means a type of cancer that started in an organ (like the lung or breast) and has either spread to other parts of the body or is severe and has not responded to usual treatments.

Why is this study being done?

The study aims to find out if ETX-19477 is safe, what the best dose is, and if it can help shrink tumours or stop them from growing in people with advanced cancer.

Will I definitely get the new drug?

If you are eligible and choose to join, you will receive ETX-19477 as part of the study. This study is not comparing it to a placebo.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and it will not affect your ongoing medical care.