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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
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 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Cetuximab 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
GenesisCare North Shore
Sydney, New South Wales, Australia
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
RECRUITINGICON Cancer Centre South Brisbane
Brisbane, Queensland, Australia
WITHDRAWNGreenslopes Private Hospital
Greenslopes, Queensland, Australia
RECRUITINGSouthern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
RECRUITINGPeninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
RECRUITINGCabrini Health
Malvern, Victoria, Australia
WITHDRAWNLinear Clinical Research
Perth, Western Australia, Australia
RECRUITINGThe Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
RECRUITINGNational Cancer Centre Singapore
Singapore, Singapore
RECRUITING...and 10 more locations
Incidence and Nature of Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment
Time frame: From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1
The ORR is defined as the proportion of subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), based on RECIST Version 1.1
Time frame: Up to 24 months
Number of participants with dose-limiting toxicities (DLTs)
DLTs will be assessed in the dose escalation cohorts and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment
Time frame: During the first three weeks of study treatment
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