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

NCT05910827 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2026-04-15

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

HMBD-001

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

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks

DRUG

Cetuximab

Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Hummingbird Bioscience

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2027-12-01
Completion
2027-12-31

Countries

  • Australia
  • Moldova
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910827 on ClinicalTrials.gov