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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Johann
de Bono
johann.debono@icr.ac.uk
Mrs
Lesley
McGuigan
lesley.mcguigan@cancer.org.uk
Malignant neoplasms of ill-defined, secondary and unspecified sites
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This clinical trial is looking at a drug called HMBD-001. HMBD-001 is a type of drug called a monoclonal antibody. It works by targeting a protein called HER3, that is found in high numbers on some cancer cells. By attaching itself to this protein it may then work to kill the cancer cells or to stop them growing. HMBD-001 has been tested on animals (rats and mice) in the laboratory and has shown promising activity. We now wish to find out if it will be useful in treating patients with cancer.
This clinical trial is in two parts:
Part A is a ‘dose escalation’ phase where small groups of patients will receive increasing doses of HMBD-001 to find the safest dose which best targets cancer cells.
In Arm 1, patients will receive HMBD-001 on its own (as a single agent).
In Arm 2, patients will receive HMBD-001 given with other anti-cancer drugs (in combination). This arm will not start until Arm 1 has been completed.
Part B is a ‘dose expansion’ phase where larger groups of patients with specific cancer types, known to have high levels of the protein HER3, will receive the highest doses of HMBD-001 considered to be safe in Part A.
The main aims of the clinical trial are to find out:
-The highest dose of HMBD-001 alone and in combination with other anti-cancer drugs that can be given safely to patients.
-More about the potential side effects of HMBD-001 when given alone and in combination with other anti-cancer agents and how they can be managed.
-What happens to HMBD-001 inside the body and how it affects cancer cells.
The trial will initially be conducted at three sites in the UK.
This trial is sponsored by Cancer Research UK (CRUK).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Drug;
You can take part if:
You may not be able to take part if:
1. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy (with the exception of life-long hormone suppression such as luteinising hormone-releasing hormone (LHRH) agents in prostate cancer), immunotherapy or investigational medicinal products during the previous 4 weeks before trial Cycle 1 Day 1. 2. Patients with ongoing toxic manifestations of previous treatments greater than NCI-CTCAE Grade 1. Exceptions apply see protocol. 3. Patients with symptomatic brain or leptomeningeal metastases should be excluded. Asymptomatic patients on a stable steroid dose will be eligible for the trial. 4. Women of child-bearing potential (or are already pregnant or lactating). However, those patients who meet the following points are considered eligible: •Have a negative serum or urine pregnancy test before enrolment and; •Agree to use two forms of contraception: i. one highly effective form including but not limited to: oral, injected, implanted, transdermal or intravaginal hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system or vasectomised partner; ii. plus a barrier method (for example condom plus spermicide), iii. or agreed to sexual abstinence, effective from the first administration of HMBD-001, throughout the trial and for six months after the last administration of IMP. 5. Male patients with partners of child-bearing potential. However, those patients who meet the following points are considered eligible: •Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence effective from the first administration of HMBD-001, throughout the trial and for six months after the last administration of IMP. •Non-vasectomised men with partners of child-bearing potential must also be willing to ensure that their partner uses a highly effective method of contraception for the same duration for example, hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system or sexual abstinence. •Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicide) to prevent exposure of the foetus or neonate. 6.Major surgery from which the patient has not yet recovered. 7.At high medical risk because of non-malignant systemic disease including active uncontrolled infection. Patients with previous Hepatitis C exposure but no current infection are eligible to participate. 8.Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus infection. 9.Known or suspected hypersensitivity reaction to previous biological therapy that in the opinion of the Investigator is a contraindication for their participation in this study. 10.Concurrent congestive heart failure, prior history of > = class II cardiac disease (New York Heart Association), history of clinically significant cardiac ischaemia or prior history of clinically significant cardiac arrhythmia. Patients with significant cardiovascular disease are excluded as defined by: a.History of unstable angina pectoris or myocardial infarction within six months prior to trial entry b.History or evidence of current clinically significant uncontrolled arrhythmias. Patients with controlled atrial fibrillation for > 30 days prior to trial entry are eligible. c.Coronary angioplasty or stenting within 6 months prior to trial entry. d.Presence of a ventricular arrhythmia requiring treatment e.LVEF < 50% f.QTcF > = 480 msec (> = 500msec for patients with bundle branch block) 11.Patients with an active autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Exceptions apply for controlled Type I diabetes mellitus and skin disorders. See protocol. 12. Patients receiving doses of prednisolone > 10mg daily (or equipotent doses of other corticosteroids) within 7 days prior to the first dose of study drug are not eligible unless administered as pre-medication. 13. Patients having received a live vaccination within 4 weeks prior to first dose of HMBD-001. 14. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I/IIa trial of HMBD-001. Exceptions apply see protocol. 15. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial. 16. Current or prior malignancy which could affect safety or efficacy assessment of the IMP or compliance with the protocol or interpretation of results. Exceptions apply see protocol.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by CANCER RESEARCH UK and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 49816
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