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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Sep 2026 to Nov 2025 · Site details revised at 4 of 4 sitesv7 Show 2 more changesShow less
    • Primary and study completion dates: Sep 2026 to Nov 2025
    • Site details revised at 4 of 4 sites
  2. Secondary endpoints: details revised at 6 of 13 entries Eligibility criteria expanded, about 4 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 135 to 81 Primary endpoints: 3 to 5 · Study sites: 2 to 4 · Interventions: HMBD-001 (Drug) to HMBD-001 (Drug), HMBD-001 and enzalutamide (Drug) · 4 morev5 Show 7 more changesShow less
    • Primary endpoints: 3 to 5
    • Study sites: 2 to 4
    • Interventions: HMBD-001 (Drug) to HMBD-001 (Drug), HMBD-001 and enzalutamide (Drug)
    • Eligibility criteria expanded, about 89 words
    • Secondary endpoints: 9 to 13
    • Study description expanded, about 52 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 1 to 2 Start date changed from estimate of Oct 2021 to Nov 10, 2021v3 Show 1 more changeShow less
    • Start date changed from estimate of Oct 2021 to Nov 10, 2021
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Sep 2021 to Oct 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Sep 2021 to Oct 2021
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cancer Research UK
15 trials monitored
See 2 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 13 more diseases
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov