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New drug cocktail targets Hard-to-Treat cancers

NCT ID NCT05910827

Disease control Sponsor: Hummingbird Bioscience Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new antibody called HMBD-001 combined with two existing cancer drugs (cetuximab and docetaxel) in people with advanced squamous cell cancers of the lung, head and neck, esophagus, cervix, or skin. The goal is to see if the combination is safe and can shrink tumors or delay cancer growth. About 398 participants will take part across multiple sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HMBD-001 (an antibody targeting HER3) combined with cetuximab and docetaxel
What this could lead to
If successful, this could offer a new treatment option for people with advanced squamous cell cancers who have run out of standard therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. Side effects from the drug combination are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 398 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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 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

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma nasopharyngeal carcinoma non-small cell lung carcinoma non-small cell squamous lung carcinoma skin squamous cell carcinoma squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cutaneous squamous cell carcinoma Advanced esophageal squamous cell carcinoma Advanced head and neck squamous cell carcinoma Advanced or metastatic squamous non-small cell lung cancer Cervical squamous cell carcinoma Nasopharyngeal cancinoma (NPC) Squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHA Bundang Medical Center, CHA University

    RECRUITING

    Seongnam-si, South Korea

  • Cabrini Health

    WITHDRAWN

    Malvern, Victoria, 3144, Australia

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, South Korea

  • GenesisCare North Shore

    WITHDRAWN

    Sydney, New South Wales, 2065, Australia

  • Greenslopes Private Hospital

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • ICON Cancer Centre South Brisbane

    WITHDRAWN

    Brisbane, Queensland, 4101, Australia

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Linear Clinical Research

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, Taiwan

  • Peninsula & South Eastern Haematology and Oncology Group

    RECRUITING

    Frankston, Victoria, Australia

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Southern Oncology Clinical Research Unit

    RECRUITING

    Adelaide, South Australia, 5042, Australia

  • Taipei Medical University - Shuang Ho Hospital

    RECRUITING

    Taipei, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, Taiwan

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, Singapore

  • The Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

  • The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit

    RECRUITING

    Chisinau, Moldova

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.