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Advanced or Metastatic Squamous Non-Small Cell Lung CancerPhase 1/2NCT05910827

A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

A Phase 1/2 study testing HMBD-001, Docetaxel and Cetuximab in people with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Advanced Head and Neck Squamous Cell Carcinoma, run by Hummingbird Bioscience at 20 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HMBD-001, Docetaxel and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
20 sitesin 5 countries
Study dates
5 Feb 2024to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Kevin Heller, Dr contact

+65 6978 9377

k.heller@hummingbirdbio.com

20 sites in 5 countries

Australia8 sites, 5 recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia, 5042

    Ganessan Kichenadasse

    Ganessan Kichenadasse

    Recruiting

  • ICON Cancer Centre South Brisbane

    Brisbane, Queensland, 4101

    Withdrawn

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria

    Vinod Ganju

    Vinod Prof Ganju

    Recruiting

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

    Rahul Ladwa

    Rahul Ladwa

    Recruiting

  • Cabrini Health

    Malvern, Victoria, 3144

    Withdrawn

  • Linear Clinical Research

    Perth, Western Australia, 6009

    Samantha Bowyer

    Samantha Bowyer

    Recruiting

  • GenesisCare North Shore

    Sydney, New South Wales, 2065

    Withdrawn

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Rosemary Habib

    Rosemary Dr Habib

    Recruiting

Other trials in Australia

South Korea5 sites, 5 recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Ki Hyeong Lee

    Ki Hyeong Lee

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si

    Joo-Hang Kim

    Joo-Hang Kim

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Yoon Ji Choi

    Yoon Ji Choi

    Recruiting

  • Severance Hospital

    Seoul

    Hye Ryun Kim

    Hye Ryun Kim

    Recruiting

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

    Suwon

    Byoung Yong Shim

    Byoung Yong Shim

    Recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Jen-Yu Hung

    Jen-Yu Hung

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Chun-Hui Lee

    Chun-Hui Lee

    Recruiting

  • Taipei Medical University - Shuang Ho Hospital

    Taipei

    Wei-Hong Cheng

    Wei-Hong Cheng

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Yung-Hung Lo

    Yung-Hung Lo

    Recruiting

Other trials in Taiwan

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore

    Singapore

    Aaron Tan

    Aaron Tan

    Recruiting

  • Tan Tock Seng Hospital

    Singapore

    Jens Samol

    Jens Samol

    Recruiting

Other trials in Singapore

Moldova1 site, 1 recruiting

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

    Chisinau

    Iurie Bulat

    Iurie Bulat

    Recruiting

Other trials in Moldova

About this study

Official title: A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas

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

Being tested
HMBD-001, Docetaxel, Cetuximab
Keywords
NSCLC, Non-small Cell Lung Cancer, sqNSCLC, Lung, Squamous, HER3, ErbB3, Docetaxel, Cetuximab, cervical squamous cell carcinoma, HNSCC, CSCC, ESCC, advanced squamous cell cancer, NPC, SCC
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMBD-001Drug

    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

  • DocetaxelDrug

    Docetaxel 75 mg/m^2 or 60 mg/m IV once every 3 weeks

  • CetuximabDrug

    Cetuximab 250 mg/m^2 weekly, with or without 400 mg/m^2 IV loading dose at C1D1

Study groups in NCT05910827
Study groupRoleWhat they receive
Arm AExperimentalParticipants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
Receives: Drug: HMBD-001; Drug: Docetaxel
Arm BExperimentalParticipants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment.
Receives: Drug: HMBD-001; Drug: Docetaxel; Drug: Cetuximab
Arm CExperimentalParticipants receive HMBD-001 with cetuximab
Receives: Drug: HMBD-001; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Nature of Adverse Events (AEs)

    Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, vital signs and ECG results per NCI CTCAE V5.0 Incidence of dose interruptions and modifications An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment

    Measured: From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment

  2. Number of participants with dose-limiting toxicities (DLTs) - applicable to part A

    DLTs will be assessed in the dose escalation cohorts and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment

    Measured: From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)

  3. Six months progression-free survival (PFS) - applicable to part B

    Number of participants achieving progression-free survival (PFS) at 6 months

    Measured: From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months

Secondary outcomes (3)

  1. Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1

    The ORR is defined as the proportion of subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), based on RECIST Version 1.1

    Measured: From date of enrollment (first dosing) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  2. HMBD-001 serum concentration-time profile and derived PK parameters

    Measured: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months

  3. HMBD-001 Immunogenicity Profile

    Number and percentage of participants who develop detectable ADAs

    Measured: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2023
  2. Study start5 Feb 2024
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
398 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05910827
Sponsor's protocol ID
HMBD-001-103
Status last verified
May 2026
First submitted
1 Jun 2023
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HMBD-001, Docetaxel and Cetuximab in people with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Advanced Head and Neck Squamous Cell Carcinoma, run by Hummingbird Bioscience at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Australia, South Korea, Taiwan, Singapore, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin Heller, Dr (+65 6978 9377, k.heller@hummingbirdbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Nature of Adverse Events (AEs) (time frame: From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05910827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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