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RECRUITING
NCT05910827
PHASE1/PHASE2

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

Sponsor: Hummingbird Bioscience

View on ClinicalTrials.gov

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

Official title: A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

398

Start Date

2024-02-05

Completion Date

2027-12

Last Updated

2026-05-27

Healthy Volunteers

No

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

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