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

A Phase 1 Study of PRT3789 in Participants with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

This study is for people who have advanced or spread cancers, including types like lung, breast, and colon cancer. Researchers are testing a new medicine called PRT3789. This medicine is designed for cancers that have a specific genetic change, known as a SMARCA4 mutation. It's a very early-stage study, meaning it's the first time this new medicine is being given to people. The main goal is to find out if PRT3789 is safe to use and what doses work best. They also want to see how the body handles the medicine. It's an important step in finding new ways to treat these types of cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Prelude Therapeutics Inc.

Enrolment target

Start

21 Aug 2023

gastroesophageal junction Skin Cancer/Melanoma Lung Squamous cell carcinoma Lung Adenocarcinoma non-small cell lung cancer (NSCLC)Esophageal/gastric cancer Ovarian Cancer Bladder cancer Colon adenocarcinoma Uterine/Endometrioid Adenocarcinoma Pancreatic Cancer Breast Cancer Head and Neck Squamous cell Carcinoma gastrointestinal cancer

What is this study about?

This study is testing a new medicine, called PRT3789, to see if it can help people with certain advanced cancers. "Advanced" means the cancer has grown or spread in the body. The study is particularly looking for people whose cancer has a specific change in their genes, called a SMARCA4 mutation. This mutation is like a tiny error in the cancer cell's instruction manual, and researchers believe PRT3789 might be able to target this specific error.

This is a "Phase 1" study, which means it’s one of the very first times this medicine is being given to people. The main purpose of this early stage is to find out if the medicine is safe and what dose of the medication is best. Researchers will carefully watch how people react to the medicine and how their bodies handle it. They are not primarily looking at whether it cures cancer at this stage, but rather laying the groundwork for future studies if it proves to be safe and shows promise.

This research is important because it could lead to new treatment options for people with these specific types of cancer. By understanding how PRT3789 works and if it's safe, doctors can decide whether to test it further in larger groups of people, hopefully bringing new and more targeted treatments to those who need them most. Cancers being looked at include stomach and bowel cancers, lung cancer, breast cancer, ovarian cancer, skin cancer (melanoma), and head and neck cancer, among others.

Key takeaways

This study is testing a new medicine (PRT3789) for advanced cancers with a specific SMARCA4 gene change.
It's a very early-stage (Phase 1) study focused on safety and finding the right dose.
Many types of cancer are included, such as lung, breast, and colon cancer.
Participants will have regular medical checks and tests during the study.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

The most important thing is that you have been diagnosed with an advanced or spread solid tumour (meaning it's not a blood cancer). This cancer must also have a specific genetic change, called a SMARCA4 mutation. Your cancer doctor will be able to tell if your cancer has this specific mutation. The study includes many types of cancer, such as lung cancer, breast cancer, colon cancer, ovarian cancer, stomach cancer, and melanoma.

There might be other health requirements or conditions that mean you can or cannot join the study, which your doctor will discuss with you. These are put in place to make sure the study is safe for everyone taking 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 18 years old or older?
Do you have an advanced or spread solid tumour?
Has your doctor confirmed your cancer has a SMARCA4 mutation?
Are you able to travel to study appointments regularly?
Are you open to trying a new medicine that is still in early testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, PRT3789. As it's an early-stage study, you will have regular hospital visits, tests, and check-ups to make sure the medicine is safe and to see how your body reacts to it. These appointments might include blood tests, scans, and other medical examinations to monitor your health closely.

The research doctor and nurses will explain everything you need to do and how often you'll need to come to the hospital. They will also tell you about any follow-up appointments after you stop taking the medicine. The total length of your participation will depend on how you respond to the treatment and the study plan, which will be fully explained before you agree to join.

Potential risks and benefits

Taking part in a study like this means you might be among the first to receive a new medicine that could potentially help your cancer, especially one with a specific genetic change. However, it's also important to remember that this is an early-stage study, so we don't yet know all the potential side effects or how effective the medicine will be. There could be risks of side effects from the medicine, some of which might be serious, and it may not work for everyone. You will be closely monitored by medical staff. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Netherlands
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Unverified
Germany

Common questions

What is a SMARCA4 mutation?

It's a specific genetic change or error found in some cancer cells, which the new medicine is designed to target.

Why is this called a 'Phase 1' study?

Phase 1 means it's the very first time this medicine is being given to people, mainly to check if it's safe and to find the right dose.

Will this medicine cure my cancer?

In Phase 1, the main goal is safety and dosing, not specifically cure. While it might help, the focus is on gathering essential information for future research.

What kind of tests will I have?

You will likely have regular blood tests, scans, and other medical checks to monitor your health and how your body responds to the medicine.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and it will not affect your regular medical care.