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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

February 5, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Advanced or Metastatic Squamous Non-Small Cell Lung CancerAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Esophageal Squamous Cell CarcinomaCervical Squamous Cell CarcinomaAdvanced Cutaneous 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 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly

Trial Locations (20)

2065

RECRUITING

GenesisCare North Shore, Sydney

2145

RECRUITING

Westmead Hospital, Westmead

3144

WITHDRAWN

Cabrini Health, Malvern

4101

WITHDRAWN

ICON Cancer Centre South Brisbane, Brisbane

4120

RECRUITING

Greenslopes Private Hospital, Greenslopes

5042

RECRUITING

Southern Oncology Clinical Research Unit, Adelaide

6009

RECRUITING

Linear Clinical Research, Perth

Unknown

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group, Frankston

RECRUITING

The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit, Chisinau

RECRUITING

National Cancer Centre Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital, Singapore

RECRUITING

Chungbuk National University Hospital, Cheongju-si

RECRUITING

CHA Bundang Medical Center, CHA University, Seongnam-si

RECRUITING

Korea University Anam Hospital, Seoul

RECRUITING

Severance Hospital, Seoul

NOT_YET_RECRUITING

The Catholic University of Korea St. Vincent's Hospital, Suwon

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

RECRUITING

National Cheng Kung University Hospital, Tainan City

RECRUITING

Taipei Medical University - Shuang Ho Hospital, Taipei

RECRUITING

Taipei Veterans General Hospital, Taipei

Sponsors
All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

Hummingbird Bioscience

INDUSTRY