A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

Sponsor
Hummingbird Bioscience
Study ID
NCT05910827
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cutaneous Squamous Cell Carcinoma
  • Advanced Esophageal Squamous Cell Carcinoma
  • Advanced Head and Neck Squamous Cell Carcinoma
  • Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
  • Cervical Squamous Cell Carcinoma
  • Nasopharyngeal Cancinoma (NPC)
  • Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HMBD-001 — DRUG
    HMBD-001 is a humanized Immunoglobulin G1 (IgG1) anti-Human Epidermal Growth Factor Receptor 3(HER3) monoclonal antibody (mAb). It is administered intravenously (IV) weekly
  • Docetaxel — DRUG
    Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
  • Cetuximab — DRUG
    Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1

Study Details

This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers

Key Dates

First listed
Jun 20, 2023
Start date
Feb 5, 2024
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
398 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
  • Experimental: Arm B
    Participants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment.
  • Experimental: Arm C
    Participants receive HMBD-001 with cetuximab

Primary Outcome Measure

Incidence and Nature of Adverse Events (AEs) [ Time Frame: From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment ]

Central Contacts

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