RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

This research study is looking at a new medicine called BH-30643. It's for people in the UK with a specific type of advanced lung cancer, called non-small cell lung cancer (NSCLC), which has certain genetic changes (called EGFR or HER2 mutations). The study has two main parts. The first part will find the safest and most effective dose of BH-30643. The second part will then look more closely at how well this medicine works and check for any side effects at that chosen dose. The main goal is to understand if BH-30643 can help people with this kind of lung cancer, especially if their cancer has resisted other treatments. Researchers will also look at how the body handles the medicine.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BlossomHill Therapeutics

Enrolment target

266

Start

09 Jan 2025

Estimated completion

31 Jul 2029

NSCLC (Advanced Non-small Cell Lung Cancer)

What is this study about?

This research study is about a new medicine called BH-30643, which is being tested for people in the UK who have advanced non-small cell lung cancer (NSCLC). This is a common type of lung cancer that has either spread or grown in a way that makes it harder to treat. The ‘advanced’ part means the cancer has spread from where it started. This study is specifically for people whose cancer has particular genetic changes, known as EGFR and/or HER2 mutations, which can cause the cancer to grow.

BH-30643 is a new type of drug designed to target these specific genetic changes. Some cancer cells with these changes can become resistant to current treatments, and BH-30643 aims to work even against these resistant forms. The drug is taken by mouth and is designed to specifically attack the cancer cells with these mutations, while being kinder to healthy cells. This study is important because it could offer a new treatment option for people whose lung cancer has these specific characteristics.

The study has two phases. In Phase 1, a small group of patients will receive different doses of BH-30643 to find the safest and most effective amount to give. Once this 'best dose' is found, Phase 2 will involve a larger group of patients. This phase will focus on how well the medicine shrinks tumours and whether it helps patients, as well as keeping a close eye on any side effects. Researchers will also check how the body processes the medicine.

Key takeaways

This study is for advanced non-small cell lung cancer with specific gene changes (EGFR/HER2 mutations).
It's testing a new oral medicine, BH-30643, which aims to target these cancer cells.
The study has two parts: finding the best dose and then checking how well it works.
Participants must have tried standard treatments already.
Careful checks will be done throughout the study to monitor safety and effectiveness.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes (EGFR or HER2 mutations). You would have already tried standard treatments for your cancer. Doctors will also need to see that your cancer has at least one spot that can be measured, and generally, you should be fit enough for daily activities with a good life expectancy.

There are also reasons why someone might not be able to join. For example, if you've had another type of cancer recently, or if your cancer has other specific genetic changes that the new medicine isn't designed for. You wouldn't be able to join if you have ongoing health problems from past treatments, or other significant medical conditions like serious heart problems or certain lung diseases.

Finally, if you're already taking part in another research study with an experimental treatment, you wouldn't be able to join this one. The doctors involved in the study will carefully check all your medical information to see if this study is right 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 with EGFR or HER2 gene changes?
Have you already received standard treatments for your cancer?
Are you generally well and active in daily life?
Do you have good organ function (blood, liver, kidneys)?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be given the new medicine, BH-30643, which is taken by mouth. You would have regular appointments at the hospital for check-ups, blood tests, and scans to monitor your health and how the medicine is working against your cancer. Doctors will carefully track any side effects you might experience.

The study starts by finding the right dose (Phase 1), which involves gradually increasing doses in small groups of patients. Once the best dose is found, more patients will join (Phase 2) to continue assessing the medicine's effectiveness and safety. The total duration of your participation will depend on how you respond to the treatment and the study's design, but it will involve ongoing visits and assessments for a period. More details on the exact schedule of visits and tests would be provided by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new experimental treatment for your lung cancer, which could be helpful if standard treatments haven't worked well. However, like all medicines, BH-30643 may have side effects, and some could be serious. The research team will monitor you very closely for any side effects and provide appropriate care. It's important to remember that this new medicine may not work for everyone, and there's no guarantee of benefit. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Mayo Clinic Hospital - Arizona
Verified postcode
Phoenix, United States· Recruiting
The Regents of the University of California - Irvine, CA Campus
Verified postcode
Irvine, United States· Recruiting
UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Recruiting
University of California, Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
Stanford University Medical Center
Verified postcode
Stanford, United States· Recruiting
Yale University - Cancer Center
Verified postcode
New Haven, United States· Recruiting
Georgetown University Medical Center
Verified postcode
Washington D.C., United States· Recruiting
Mayo Clinic - Florida
Verified postcode
Jacksonville, United States· Recruiting
Sarah Cancer Research Institution - Florida Cancer Specialist
Verified postcode
Orlando, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Verified postcode
Chicago, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting

Common questions

What is NSCLC?

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It means the cancer cells are larger than those in 'small cell' lung cancer.

What are EGFR and HER2 mutations?

These are changes in certain genes within your cancer cells. These changes can make cancer grow and sometimes respond differently to treatments. This study specifically targets these changes.

What does 'locally advanced or metastatic' mean?

'Locally advanced' means the cancer has grown into nearby tissues. 'Metastatic' means the cancer has spread from the lung to other parts of the body.

Will I know if I'm getting the active drug or a placebo?

This study is 'open label', which means both you and your doctors will know that you are receiving the active study medicine, BH-30643, and not a placebo (dummy drug).

What is a 'Phase 1/2' study?

This means it's an early-stage study. Phase 1 focuses on finding a safe dose, and Phase 2 then looks at how well the treatment works and its side effects in more detail.

How to find out more

Sponsor Contact

clinicaltrials@bhtherapeutics.com (858) 732-3880 Official trial record

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