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
NCT ID: NCT05910827
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
98 participants
INTERVENTIONAL
2024-02-05
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
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
Docetaxel
Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Arm B
Participants receive HMBD-001 with docetaxel plus cetuximab
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
Docetaxel
Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Cetuximab
Cetuximab 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Arm C
Participants receive HMBD-001 with cetuximab
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
Cetuximab
Cetuximab 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Interventions
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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
Docetaxel
Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Cetuximab
Cetuximab 400 mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Hummingbird Bioscience
INDUSTRY
Responsible Party
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Locations
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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 City, , Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Nick Pavlakis
Role: primary
Pei Ding
Role: primary
Rahul Ladwa
Role: primary
Ganessan Kichenadasse
Role: primary
Vinod Ganju
Role: primary
Samantha Bowyer
Role: primary
Iurie Bulat
Role: primary
Aaron Tan
Role: primary
Jens Samol
Role: primary
Ki Hyeong Lee
Role: primary
Joo-Hang Kim
Role: primary
Yoon Ji Choi
Role: primary
Hye Ryun Kim
Role: primary
Byoung Yong Shim
Role: primary
Jen-Yu Hung
Role: primary
Chun-Hui Lee
Role: primary
Wei-Hong Cheng
Role: primary
Yuh-Min Chen
Role: primary
Other Identifiers
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HMBD-001-103
Identifier Type: -
Identifier Source: org_study_id
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