Phase I/IIa trial of HMBD-001 in advanced HER3 positive solid tumours
Research type
Research Study
Full title
A Cancer Research UK Phase I/IIa open label, dose escalation and expansion trial of HMBD-001 (an anti-HER3 monoclonal antibody) given intravenously as a single agent and in combination in patients with advanced HER3 positive solid tumours.
IRAS ID
298897
Contact name
Johann De Bono
Contact email
Sponsor organisation
Cancer Research UK
Eudract number
2020-005891-36
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
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).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0477
Date of REC Opinion
9 Sep 2021
REC opinion
Further Information Favourable Opinion