Phase
Condition
Cervical Cancer
Esophageal Cancer
Lung Cancer
Treatment
Cetuximab
Docetaxel
HMBD-001
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to understand and be willing to sign an informed consent form
Males and females aged over 18 years (or having reached the age of majorityaccording to local laws if the age of majority is > 18 years of age)
Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
Arm B only: Locally advanced or metastatic squamous non-small cell lung cancerfor which all available standard of care treatment options have been exhaustedor refused and for which at least one lesion is measurable
Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC or cervical SCCwith at least one prior line of systemic therapy,
Have an estimated life expectancy of at least 3 months
Participants must be willing to provide a fresh tumor biopsy sample
Have adequate organ function
Females must be non-pregnant and non-lactating, willing to use a highlyeffective method of contraception from screening until study completion or beeither surgically sterile or post-menopausal
Males must be surgically sterile, abstinent, or if engaged in sexual relationswith a woman of child-bearing potential, the participant and his partner mustbe surgically sterile or using an acceptable, highly effective contraceptivemethod from screening until study completion
Exclusion
Exclusion Criteria:
Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targetsEpidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Priortreatment with docetaxel is allowed for Arm C
Receipt of prior targeted therapy, including but not limited to those targetingEGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions ormutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12Cmutation
Persistent clinically significant toxicities (Grade ≥2) from previousanti-cancer therapy except for Grade >2 toxicities that are consideredunlikely to put the participant at an increased risk of treatment-relatedtoxicity and/or impact the study results e.g., alopecia
Most recent anti-cancer therapy including radiotherapy at least 4 weeks, ornitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever isshorter prior to starting the assigned study treatment
Symptomatic primary Central Nervous System (CNS) cancer or metastases unlessthe symptoms are stable for at least 28 days prior to the first dose of thestudy drug and any symptoms have returned to baseline
Evidence of abnormal cardiac function
History of uncontrolled allergic reactions and/or known expectedhypersensitivity to the study drugs used in the treatment arm to which theparticipant is to be enrolled into
Any other known active malignancy except for treated cervical intraepithelialneoplasia, or non-melanoma skin cancer
Any uncontrolled illness or significant uncontrolled condition(s) requiringsystemic treatment
Known Human Immunodeficiency Virus (HIV) infection
Active hepatitis B or hepatitis C infection
Pregnant or breast feeding
COVID 19 infection within 3 months prior to the first dose of the study drug
COVID 19 vaccination within 14 days prior to the first dose of the study drug
Treatment with strong inhibitors or inducers of CYP3A4
Study Design
Connect with a study center
GenesisCare North Shore
Sydney, New South Wales 2065
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
ICON Cancer Centre South Brisbane
Brisbane, Queensland 4101
AustraliaSite Not Available
Greenslopes Private Hospital
Greenslopes, Queensland 4120
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit
Adelaide, South Australia 5042
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria
AustraliaActive - Recruiting
Cabrini Health
Malvern, Victoria 3144
AustraliaSite Not Available
Linear Clinical Research
Perth, Western Australia 6009
AustraliaActive - Recruiting
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Chisinau,
Moldova, Republic ofActive - Recruiting
National Cancer Centre Singapore
Singapore,
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore,
SingaporeActive - Recruiting
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