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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination With Cetuximab in Participants With Advanced Squamous Cell Cancers

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Ability to understand and be willing to sign an willing to sign a consent form form - Males and females aged over 18 years (or having reached the age of majority according 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 cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable - Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC or cervical SCC with at least one prior line of systemic therapy, - Have an estimated expected to live at least 3 months - Participants must be willing to provide a fresh tumor biopsy sample - Have your organs (liver, kidneys, etc.) are working well enough based on blood tests - Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal - Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion Who Should NOT Join This Trial: - Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C - Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 majority according 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 cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC or cervical SCC with 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 highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion Exclusion Criteria: * Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline * Evidence of abnormal cardiac function * History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic 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

Treatments Being Tested

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

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