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New treatment option for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Official title A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
ClinicalTrials.gov ID: NCT05910827
What this study is testing
What is HMBD-001?
HMBD-001 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced or metastatic squamous non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,
You likely can't join if
- Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including...
- Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET...
- Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \>2 toxicities that are considered...
- 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...
- 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...
- Evidence of abnormal cardiac function
See the full eligibility 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, cervical SCC, NPC and other SCCs 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Brisbane, Queensland, Australia
- Greenslopes, Queensland, Australia
- Adelaide, South Australia, Australia
- Frankston, Victoria, Australia
- Malvern, Victoria, Australia
- Perth, Western Australia, Australia
- Chisinau, Moldova
- Singapore, Singapore
- Cheongju-si, South Korea
- Seongnam-si, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Westmead, New South Wales, Australia; Brisbane, Queensland, Australia; Greenslopes, Queensland, Australia; Adelaide, South Australia, Australia; Frankston, Victoria, Australia and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.