HMBD-001 in Advanced HER3 Positive Solid Tumours

Ovarian Cancer Clinical Trial

Official title: HMBD-001 (an Anti-HER3 Monoclonal Antibody) Given Intravenously as a Single Agent and in Combination in Patients With Advanced HER3 Positive Solid Tumours

Status Recruiting

Clinical Trial Summary

This clinical trial is evaluating a drug called HMBD-001 (an anti-HER3 monoclonal antibody) in patients with advanced HER3 positive solid tumours. The main aims are to find out the maximum dose of HMBD-001 that can be given safely to patients alone and in combination with other anti-cancer agents, more about the potential side effects of HMBD-001 and how these can be treated and what happens to HMBD-001 inside the body and how it affects cancer cells.

Clinical Trial Description

HMBD-001 is a type of drug called a monoclonal antibody, which works by targeting a protein called HER3, that is found in high numbers in some types of cancers including those which contain NRG1 gene fusions. By attaching itself to this protein it may then work to kill the cancer cells or to stop them growing.

This is a first-in-human clinical trial which has 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).

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 or a confirmed NRG1 gene fusion will receive the highest doses of HMBD-001 considered to be safe in Part A either alone as single agent or in combination with other anti-cancer drugs.

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 potential anti-tumour activity of HMBD-001 as a single agent and in various combination regimens in specific tumour types of HER3 expressing tumours or tumours with NRG1 gene fusions. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05057013
• Study type: Interventional
• Source: Cancer Research UK
• Contact: Johann de Bono, Prof
• Phone: +44 (0)208 722 4029
• Email: johann.debono@icr.ac.uk
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 10, 2021
• Completion date: September 2026