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

Last updated: April 17, 2025
Sponsor: Hummingbird Bioscience
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Esophageal Cancer

Lung Cancer

Treatment

Cetuximab

Docetaxel

HMBD-001

Clinical Study ID

NCT05910827
HMBD-001-103
  • Ages > 18
  • All Genders

Study 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, and HMBD-001 in combination with cetuximab in participants with advanced Squamous Cell Cancers

Eligibility Criteria

Inclusion

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 majorityaccording 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 cancerfor which all available standard of care treatment options have been exhaustedor refused and for which at least one lesion is measurable

  • Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC or cervical SCCwith 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 highlyeffective method of contraception from screening until study completion or beeither surgically sterile or post-menopausal

  • Males must be surgically sterile, abstinent, or if engaged in sexual relationswith a woman of child-bearing potential, the participant and his partner mustbe surgically sterile or using an acceptable, highly effective contraceptivemethod from screening until study completion

Exclusion

Exclusion Criteria:

  • Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targetsEpidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Priortreatment with docetaxel is allowed for Arm C

  • Receipt of prior targeted therapy, including but not limited to those targetingEGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions ormutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12Cmutation

  • Persistent clinically significant toxicities (Grade ≥2) from previousanti-cancer therapy except for Grade >2 toxicities that are consideredunlikely to put the participant at an increased risk of treatment-relatedtoxicity and/or impact the study results e.g., alopecia

  • Most recent anti-cancer therapy including radiotherapy at least 4 weeks, ornitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever isshorter prior to starting the assigned study treatment

  • Symptomatic primary Central Nervous System (CNS) cancer or metastases unlessthe symptoms are stable for at least 28 days prior to the first dose of thestudy drug and any symptoms have returned to baseline

  • Evidence of abnormal cardiac function

  • History of uncontrolled allergic reactions and/or known expectedhypersensitivity to the study drugs used in the treatment arm to which theparticipant is to be enrolled into

  • Any other known active malignancy except for treated cervical intraepithelialneoplasia, or non-melanoma skin cancer

  • Any uncontrolled illness or significant uncontrolled condition(s) requiringsystemic 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

Study Design

Total Participants: 98
Treatment Group(s): 3
Primary Treatment: Cetuximab
Phase: 1/2
Study Start date:
February 05, 2024
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • GenesisCare North Shore

    Sydney, New South Wales 2065
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • ICON Cancer Centre South Brisbane

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Greenslopes Private Hospital

    Greenslopes, Queensland 4120
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia 5042
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria
    Australia

    Active - Recruiting

  • Cabrini Health

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Linear Clinical Research

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

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

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore,
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore,
    Singapore

    Active - Recruiting

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