A trial of HMBD-001 for solid cancers that have spread

The following bullet points are a summary of the entry conditions for people having HMBD-001 on its own.

Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

Dose escalation (part A) - please note, this part of the trial is now closed to recruitment
This part was for people with several different cancer types. 

Dose expansion (part B, group 1) - open to recruitment 
To join the second part of the trial all of the following must apply. You:

• have prostate cancer that has got worse despite having hormone treatment
• have low levels of the hormone testosterone in the blood. And you must have had abiraterone, enzalutamide, apalutamide or darolutamide in the past. 
• have a PSA level that is more than 1ng/ml
• have high levels of the HER3 protein on your cancer cells and you have cancer that has PTEN in the prostate cancer cells. This might not apply if you have a particular gene change that the trial team will look for called NRG1 gene fusion.
• are willing to give a new sample of tissue for the trial team to do some tests on or there is a sample of tissue the team can access. This is to check for HER3 and PTEN. You must be willing to give a sample if there isn’t one available.
• have satisfactory blood test results 
• are fit and able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1) 
• are willing to use reliable contraception during the trial and for a period after if there is any chance your partner could become pregnant 
• are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have had chemotherapy, hormone therapy  (unless it was a drug called a luteinising hormone releasing hormone (LHRH) for prostate cancer), immunotherapy , an experimental drug or radiotherapy  within 4 weeks of starting trial treatment. You may be able to take part if you had radiotherapy to help cancer symptoms (palliative treatment).
• have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
• have side effects from past treatments unless they are mild. This is apart from hair loss or moderate numbness and tingling in the hands or feet (peripheral neuropathy ).
• are taking part or plan to take part in another clinical trial using an experimental treatment. You may be able to join a non treatment trial. 

Medical conditions
You cannot join this trial if any of these apply. You:

• have had a reaction to a targeted drug in the past 
• have had major surgery and you aren’t fully better 
• have HIV, hepatitis B, an active hepatitis C infection or any other severe active infection that isn’t well controlled with medication 
• have had a heart attack, angina  or surgery to repair a blocked artery in your heart in the last 6 months. You can’t take part if your heart doesn’t work well or you have another significant heart problem  that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• have an autoimmune condition  that needs treatment apart from certain ones. Your doctor will know about this. 
• have had treatment that damps down the immune system . This includes steroids within one week of starting trial treatment unless it was a low dose.
• are taking medication to thin the blood, for example warfarin
• have fits (seizures) or you are at risk of this happening. Your doctor will know this. 
• have or have had another cancer that your doctor thinks will affect you taking part. You may be able to take part if you have had non melanoma skin cancer , early bladder cancers or very early cancers (carcinoma in situ or CIS)  that has been successfully treated.
• have another medical condition that your doctor or the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

• are allergic to enzalutamide or anything it contains
• have had enzalutamide or a similar drug in the past and you had to stop taking it due to side effects or you had a lower dose due to side effects 
• have had a live vaccine  within 4 weeks of having the first dose of HMBD-001. This doesn’t include COVID-19 vaccines as these are not live vaccines.