Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours

This research is looking into a new medication called HMBD-001, designed for people with advanced cancers that have a specific marker called HER3. HER3 is a protein found on some cancer cells, and this drug aims to block it. The study has two main parts. First, we'll give HMBD-001 alone in small, increasing doses to find the safest amount. Then, in larger groups, we'll test this safe dose, sometimes combined with another cancer drug called enzalutamide, which is already used for prostate cancer. Our goals are to find the best dose, learn about any side effects and how to manage them, and see if the drug can help stop cancer from growing in various cancer types.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Cancer Research UK

Enrolment target

Start

10 Nov 2021

Estimated completion

01 Nov 2025

Bladder Cancer Triple Negative Breast Cancer Castration-resistant Prostate Cancer Cervical Cancer RAS Wild Type Colorectal Cancer Endometrial Cancer Gastric Cancer Hepatocellular Carcinoma (HCC)Melanoma Non-small Cell Lung Cancer (NSCLC)Oesophageal Cancer Ovarian Cancer Pancreatic Cancer Squamous Cell Cancer of the Head and Neck

What is this study about?

This research study is about a new drug called HMBD-001. It's designed to treat advanced cancers that have a specific feature: a protein called HER3. Think of HER3 as a tiny switch on cancer cells that can help them grow. HMBD-001 is a special type of medicine called a 'monoclonal antibody' which acts like a smart key, designed to specifically lock onto and block this HER3 switch. By doing this, we hope the drug can either kill the cancer cells or stop them from growing.

This study is divided into two main parts. In the first part, small groups of people will receive HMBD-001 on its own, with the dose gradually increasing. This helps us find the safest dose that also works best against the cancer. In the second part, larger groups of people, specifically those with cancers known to have a lot of HER3 or a related gene change called NRG1, will receive the drug. Sometimes, HMBD-001 will be given with another approved cancer medicine, like enzalutamide, which is used for prostate cancer. Our key goals are to figure out the right dose, understand any side effects and how to look after people taking the drug, and see how it affects cancer cells.

Ultimately, this study aims to see if HMBD-001, either alone or with other treatments, can be a helpful new option for people living with several types of advanced cancer, including bladder cancer, different types of breast cancer, lung cancer, and others. We're trying to learn as much as possible to help improve future cancer treatments.

Key takeaways

This study is testing a new drug (HMBD-001) for advanced cancers.
It targets a protein called HER3 on cancer cells.
The study aims to find safe doses and check for side effects.
It might be given alone or with another drug (enzalutamide).
It's for people aged 16+ with certain advanced cancer types.
Participation involves regular clinic visits and tests.

Who may be eligible?

This study is looking for adults aged 16 and older who have an advanced solid cancer that has either come back or hasn't responded to usual treatments, or for which there are no standard treatment options left. Your cancer must also show high levels of the HER3 protein or have a specific gene change called NRG1.

For some participants, especially those with advanced prostate cancer, there are extra requirements. Your prostate cancer must be a specific type that has spread and needs to be resistant to hormone therapy. You would also need to have low testosterone levels and have already received certain hormone-blocking medicines. In all cases, you need to be well enough to take part, have a reasonable life expectancy, and your blood tests need to be within a healthy range.

It's important to discuss your medical history and current health with your doctor to see if this study could be right for you. They can check if your specific cancer type and your overall health meet the study's requirements.

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 16 years old or older?
Do you have an advanced solid cancer that has progressed or for which standard treatments aren't suitable?
Has your doctor confirmed that your cancer has high levels of HER3 protein or a specific NRG1 gene change?
Are you generally well enough to take part in a study, as assessed by your doctor?
If you have prostate cancer, has it spread, is it resistant to hormone treatment, and have you already had certain hormone-blocking medicines?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be taking a new drug called HMBD-001. This drug is given into a vein (like a drip). The study has two parts. In the first part, you'll receive HMBD-001 on its own, and the dose might be slowly increased for different groups of people to find the best and safest amount. In the second part, if you have prostate cancer, you might receive HMBD-001 along with another approved prostate cancer drug called enzalutamide, which is taken as tablets.

Throughout the study, you'll have regular visits to the clinic. These visits will involve blood tests to check how the drug is working and to monitor for any side effects. You'll also have scans, like CT or MRI scans, to see how your cancer is responding. The doctors and nurses will ask you how you're feeling and carefully monitor your health. The total time you'd be in the study can vary depending on how you respond to the treatment, but you would have regular follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that HMBD-001 might help to slow down or stop the growth of your cancer, especially if other treatments haven't worked or are not suitable. However, because HMBD-001 is a new drug, we don't fully know how effective it will be or what all the possible side effects are. We will monitor you very closely for any side effects, which could range from mild to serious. You will be fully informed of all known and potential risks before you decide to participate, and importantly, you can withdraw from 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.

Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom
The Christie Hospital
Verified postcode
Manchester, United Kingdom
Freeman Hospital, Newcastle
Verified postcode
Newcastle, United Kingdom
Churchill Hospital
Verified postcode
Oxford, United Kingdom

Common questions

What is HER3 and why is it important?

HER3 is a protein found on the surface of some cancer cells. In some cancers, having a lot of HER3 can help the cancer grow. This new drug is designed to block HER3.

Is HMBD-001 a chemotherapy drug?

No, HMBD-001 is not traditional chemotherapy. It's a 'monoclonal antibody', which is a type of targeted therapy designed to specifically attack cancer cells with the HER3 protein, rather than generally affecting rapidly growing cells.

What is enzalutamide and why is it used in this study?

Enzalutamide is a medication already approved for treating prostate cancer. In this study, it's being tested alongside HMBD-001 in some prostate cancer patients to see if the combination works better than either drug alone.

How long will I be in the study if I join?

The length of time you participate can vary. You'll continue in the study as long as the treatment is helping you and you are tolerating it well. Your doctors will discuss this with you.

Can I continue my other medications while in the study?

This will depend on your current medications. The study team will review all your medicines to make sure they don't interfere with the study drug or your safety. You will need to tell them about all drugs, supplements, and herbal remedies you are taking.