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Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05910827
Recruitment Status : Recruiting
First Posted : June 20, 2023
Last Update Posted : November 21, 2023
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Hummingbird Bioscience

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Drug: HMBD-001 Drug: Docetaxel Drug: Cetuximab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 2023
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A
All participants receive HMBD-001 with docetaxel
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 IV once every 3 weeks

Experimental: Arm B
All participants receive HMBD-001 with docetaxel plus cetuximab
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 IV once every 3 weeks

Drug: Cetuximab
Cetuximab 400 mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly

Primary Outcome Measures :
  1. 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 ]
    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

  2. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: During the first three weeks of study treatment ]
    DLTs will be assessed during the safety run-in phase 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

  3. Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 [ Time Frame: Up to 24 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to understand and be willing to sign an informed consent form

    • Males and females aged over 18 years
    • Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
    • 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
    • Tumor has known wild type status for selected genes
    • 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

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05910827

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Contact: Kon Yew Kwek, BMBCh, DPhil +65 6979 5574

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Australia, New South Wales
GenesisCare North Shore Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Nick Pavlakis         
Principal Investigator: Nick Pavlakis         
Australia, Queensland
ICON Cancer Centre South Brisbane Not yet recruiting
Brisbane, Queensland, Australia, 4101
Contact: Vladimir Andelkovic         
Principal Investigator: Vladimir Andelkovic         
Australia, South Australia
Southern Oncology Clinical Research Unit Not yet recruiting
Adelaide, South Australia, Australia, 5042
Contact: Ganessan Kichenadasse         
Principal Investigator: Ganessan Kichenadasse         
Australia, Victoria
Cabrini Health Recruiting
Malvern, Victoria, Australia, 3144
Contact: Gary Richardson         
Principal Investigator: Gary Richardson         
Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia, 6009
Contact: Samantha Bowyer         
Principal Investigator: Samantha Bowyer         
Sponsors and Collaborators
Hummingbird Bioscience
Merck KGaA, Darmstadt, Germany
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Responsible Party: Hummingbird Bioscience Identifier: NCT05910827    
Other Study ID Numbers: HMBD-001-103
First Posted: June 20, 2023    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hummingbird Bioscience:
Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological