Clinical Trial

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

Active, Not Recruiting Phase 1/2

Record status

This record was last updated August 11, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.

Summary

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

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2021-09-24; most recent amendment 2025-08-06.

Status change: Recruiting → Active, Not Recruiting 2025-08-06

Status change: Not Yet Recruiting → Recruiting 2021-10-11

Trial Details

NCT Number	NCT05057013
Lead Sponsor	Cancer Research UK Collaborators: Hummingbird Bioscience
Conditions	Bladder Cancer, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, Cervical Cancer, RAS Wild Type Colorectal Cancer, Endometrial Cancer, Gastric Cancer, Hepatocellular Carcinoma (HCC) +6 more
Enrollment	81 participants
Start Date	2021-11-10
Primary Completion	2025-11 (estimated)
Study Completion	2025-11 (estimated)
Updated on ClinicalTrials.gov	2025-08-11