RecruitingPHASE1, PHASE2INTERVENTIONAL

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

This clinical trial is designed for individuals in the UK who have a type of advanced lung cancer called Non-Small Cell Lung Cancer (NSCLC). Specifically, it's for those whose cancer has certain genetic changes (called EGFR or HER2 exon 20 insertion mutations). If previous standard treatments haven't worked, or if you can't have them, this study might be an option. The main goals are to find out if a new drug, STX-721/PFL-721, is safe and how well your body handles it. Researchers also want to see if this new drug can help shrink or control the cancer. This is an early-stage study, meaning it's one of the first times this drug is being tested in people with this condition. It's an important step in finding new ways to treat lung cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Pierre Fabre Medicament

Enrolment target

345

Start

26 Sep 2023

Estimated completion

01 Dec 2029

Non-Small Cell Lung Cancer NSCLC EGFR/HER2 Exon 20 Insertion Mutation

What is this study about?

This research study is looking into a new medicine called STX-721/PFL-721 for people living with a specific type of advanced lung cancer. This lung cancer is known as Non-Small Cell Lung Cancer (NSCLC) and has particular changes in its genes, called EGFR or HER2 exon 20 insertion mutations. These genetic changes can make the cancer behave differently and sometimes harder to treat with existing medicines.

The study has two main parts. The first part is about safety. Researchers want to find the right dose of the new medicine that is both effective and has manageable side effects. They will carefully watch for any side effects and how the medicine moves through your body. The second part of the study will then look more closely at whether the medicine helps to shrink the cancer or stop it from growing, using the best dose found in the first part.

Taking part in a study like this is a big decision. It's important to remember that this is a new medicine, and while it shows promise in early tests, we don't yet know for sure how well it will work for human patients. Clinical trials are a vital part of developing new treatments, and your participation could help others with similar conditions in the future.

Key takeaways

This study is for advanced Non-Small Cell Lung Cancer (NSCLC) with specific genetic changes.
It's testing a new, experimental drug (STX-721/PFL-721) for safety and effectiveness.
Participants must have tried or be unable to have standard treatments.
Regular hospital visits, tests, and scans will be needed.
This is an early-stage study, meaning the drug is still being thoroughly investigated.
You can stop participating at any time without disrupting your usual care.

Who may be eligible?

To join this study, you must be at least 18 years old and have advanced Non-Small Cell Lung Cancer (NSCLC) that your doctor doesn't think can be cured by surgery or radiation. Your cancer cells must also have specific genetic changes called EGFR or HER2 exon 20 insertion mutations, which will be checked from a recent or stored sample of your cancer tissue. You should have already tried and not responded well to, or be unable to have, standard treatments for your cancer. You also need to be well enough to take part, meaning you can mostly look after yourself. The cancer should also show up clearly on scans.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has specific combinations of other genetic changes, or if you've had another type of cancer within the last two years. If your cancer has spread to your brain or spinal cord and is causing symptoms, you wouldn't be able to participate. You also shouldn't have any serious side effects from previous cancer treatments that haven't gotten better, or any other health condition that the doctors think would make the study unsafe 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 advanced Non-Small Cell Lung Cancer (NSCLC) that can't be cured by surgery or radiation?
Has your cancer been tested and confirmed to have EGFR or HER2 exon 20 insertion genetic changes?
Have you already tried at least one standard treatment for your cancer, or are you unable to have them?
Are you generally well enough to mostly look after yourself?
Is your cancer clearly visible on scans?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be receiving the new investigational medicine, STX-721/PFL-721. You will need to attend regular clinic visits where doctors will monitor your health, check for any side effects, and see how well the medicine is working. These visits will involve blood tests, physical examinations, and scans (like CT scans).

The study starts by carefully increasing the dose of the medicine for small groups of participants until the safest and most effective dose is found. Once this 'recommended dose' is established, more participants will receive it to further understand its effects. The exact number of visits and the total length of time you'd be in the study will depend on how you respond to the treatment and which part of the study you join, but studies like this typically involve many visits over several months or even longer. Your medical team will explain the schedule for your specific case in detail.

Potential risks and benefits

Participating in this trial might offer a potential benefit: access to a new drug that could help control your lung cancer if other treatments haven't worked. However, it's important to remember this is an experimental drug, and there's no guarantee it will be effective for you. Like all medicines, STX-721/PFL-721 may cause side effects, some of which could be serious or unknown. The study team will monitor you closely for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (24)

City of Hope
Verified postcode
Duarte, United States· Recruiting
City of Hope
Verified postcode
Huntington Beach, United States· Recruiting
City of Hope
Verified postcode
Irvine, United States· Recruiting
Levine Cancer Institute - Charlotte
Verified postcode
Charlotte, United States· Recruiting
Thomas Jefferson University Research Facility
Verified postcode
Philadelphia, United States· Recruiting
SCRI Oncology Partners - PPDS
Verified postcode
Nashville, United States· Recruiting
University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
University of Utah - Huntsman Cancer Institute - PPDS
Verified postcode
Salt Lake City, United States· Recruiting
NEXT Virginia
Verified postcode
Fairfax, United States· Recruiting
EDOG Institut de Cancerologie de l'Ouest - PPDS
Verified postcode
Saint-Herblain, France· Recruiting
Institut Claudius Regaud - PPDS
Verified postcode
Toulouse, France· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What type of lung cancer is this study for?

This study is for a specific type of advanced lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has certain genetic changes (EGFR or HER2 exon 20 insertion mutations).

What is the new medicine being tested?

The new medicine is called STX-721/PFL-721. It's an experimental drug, not yet approved for general use.

Why is this study important?

This study aims to find a new, potentially better treatment for advanced lung cancer that has specific genetic changes and hasn't responded to standard treatments.

Will I get the new drug if I join?

Yes, all participants in this study will receive the investigational drug STX-721/PFL-721, as there is no placebo group.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Adele De MASSON, clinical devlopment director, MD, PhD

pfl721_medical.team@pierre-fabre.com 33 772344916 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.