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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
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 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1
GenesisCare North Shore
Sydney, New South Wales, Australia
WITHDRAWNWestmead 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)
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, vital signs and ECG results per NCI CTCAE V5.0 Incidence of dose interruptions and modifications 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
Number of participants with dose-limiting toxicities (DLTs) - applicable to part A
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: From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)
Six months progression-free survival (PFS) - applicable to part B
Number of participants achieving progression-free survival (PFS) at 6 months
Time frame: From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months
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: From date of enrollment (first dosing) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
HMBD-001 serum concentration-time profile and derived PK parameters
Time frame: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months
HMBD-001 Immunogenicity Profile
Number and percentage of participants who develop detectable ADAs
Time frame: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months
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