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Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers, and HMBD-001 + Cetuximab in Advanced Squamous Cell Cancers
Sponsor: Hummingbird Bioscience
Summary
This is a phase 1b multi-center, open-label study of HMBD-001 in combination with docetaxel with or without cetuximab in participants with locally advanced or metastatic squamous Non-Small Cell Lung Cancers, and HMBD-001 in combination with cetuximab in participants with advanced Squamous Cell Cancers
Official title: A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination With Cetuximab in Participants With Advanced Squamous Cell Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2024-02-05
Completion Date
2026-03-01
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
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
Docetaxel
Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Cetuximab
Cetuximab 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Locations (20)
GenesisCare North Shore
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
ICON Cancer Centre South Brisbane
Brisbane, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Cabrini Health
Malvern, Victoria, Australia
Linear Clinical Research
Perth, Western Australia, Australia
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
National Cancer Centre Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Chungbuk National University Hospital
Cheongju-si, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan