Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of PRT7732, an Oral SMARCA2 Degrader, in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

This study is testing a new tablet called PRT7732 for people with advanced cancers that have a specific genetic change, known as a SMARCA4 mutation. This includes certain types of stomach, oesophageal (food pipe) and lung cancers, as well as other solid tumours. This is a very early-stage study, meaning it’s the first time PRT7732 is being given to people. The main goals are to see if the treatment is safe, what side effects it might cause, and how it affects the body. The research team will also try to find the best dose of the drug. Taking part in such a study helps doctors learn more about new ways to fight cancer, potentially leading to new treatment options in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Prelude Therapeutics Inc.

Enrolment target

Start

21 Jan 2025

esophageal gastric or gastroesophageal junction adenocarcinoma esophageal gastric or gastroesophageal junction squamous cell carcinoma Non-small cell lung cancer (NSCLC)Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

What is this study about?

Doctors are always looking for new ways to treat cancer, especially when it has spread or is advanced. This particular study is trying out a brand-new medicine, a tablet called PRT7732. This medicine is designed to target a specific weakness found in some cancer cells. Some cancers have a change in their genes called a SMARCA4 mutation. This change can help cancer grow, and researchers hope that PRT7732 can stop this process.

This study is a 'Phase 1' study. This is the very first step in testing a new drug in people. At this stage, the main thing doctors want to find out is whether the drug is safe to use and what doses people can take without too many problems. They also want to understand how the drug behaves in the body – for example, how it's absorbed and broken down.

By taking part, you would be helping doctors learn important information about PRT7732. Even though early-stage studies don't always directly lead to a cure, they are a vital step in discovering new treatments that might help people with cancer in the future. The information gathered from this study will help decide if PRT7732 should be tested in larger groups of people.

Key takeaways

This study is testing a new tablet for advanced cancers with a specific gene change (SMARCA4 mutation).
It's a 'Phase 1' study, meaning it's the first time the drug is given to people, focusing on safety.
The study includes certain oesophageal, stomach, and lung cancers, among others.
While there's no guarantee of benefit, participants get access to a new experimental treatment.
You will be closely monitored for side effects throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old. The study is open to both men and women. It’s important that your cancer has a specific change in its genes called a SMARCA4 mutation. This includes certain types of advanced or spreading cancers affecting the food pipe (oesophageal), stomach (gastric), or lungs (non-small cell lung cancer), or other advanced solid tumours.

Before you can join, a doctor will need to check your medical history, do some tests, and make sure that this study is the right fit for you. There will be other specific health requirements that you will need to meet to make sure it's safe for you to take part.

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 at least 18 years old?
Do you have advanced or metastatic (spreading) cancer?
Has your doctor confirmed that your cancer has a 'SMARCA4 mutation'?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a number of tests and checks to make sure you are suitable. Once you've joined, you would take the PRT7732 tablet. The study team would closely monitor you for any side effects and to see how your body is reacting to the treatment. This will involve regular visits to the clinic for check-ups, blood tests, and scans.

The number of visits and the types of tests will depend on which part of the study you are in, as they try to find the safest and most effective dose. You'll be part of the study for as long as the treatment is helping you and you are not experiencing severe side effects. There might also be follow-up appointments after you stop taking the treatment. Your doctors and the study team will explain everything in detail, including how long each visit might take and the full schedule of tests.

Potential risks and benefits

Participating in an early-stage study like this has both potential benefits and risks. A potential benefit is access to a new experimental treatment that isn't widely available, which might help your specific cancer. However, as this is a new drug, the full range of side effects is not yet known, and there's no guarantee that the treatment will be effective for you. You might experience side effects, some of which could be serious. The study team will closely monitor you and provide care for any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Spain

Common questions

What is a 'Phase 1' study?

It's the first time a new drug is tested in people. The main goals are to check if it's safe and how it works in the body.

What is a 'SMARCA4 mutation'?

It's a specific change in the genes of some cancer cells that can help the cancer grow. This new drug aims to target it.

Will this drug cure my cancer?

It's too early to know if this drug will cure cancer. The main goal is to see if it's safe and what effects it has.

How long will I be in the study?

You'll take part as long as the treatment is helping you and you are not having severe side effects. The study team will explain the details.

Can I stop participating at any time?

Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.