Ireland
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Recruiting Phase 1/2

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

NCT05910827 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2024-02-05
Last updated
2026-05-27

Condition(s) studied

Advanced or Metastatic Squamous Non-Small Cell Lung CancerAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Esophageal Squamous Cell CarcinomaCervical Squamous Cell CarcinomaAdvanced Cutaneous Squamous Cell CarcinomaNasopharyngeal Cancinoma (NPC)Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

HMBD-001 →Docetaxel →Cetuximab →

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

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

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and Nature of Adverse Events (AEs) — From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
    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
  • Number of participants with dose-limiting toxicities (DLTs) - applicable to part A — From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)
    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
  • Six months progression-free survival (PFS) - applicable to part B — From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months
    Number of participants achieving progression-free survival (PFS) at 6 months

Trial sites (20)

FacilityCityRegionStatus
GenesisCare North Shore Sydney New South Wales Withdrawn
Westmead Hospital Westmead New South Wales Recruiting
ICON Cancer Centre South Brisbane Brisbane Queensland Withdrawn
Greenslopes Private Hospital Greenslopes Queensland Recruiting
Southern Oncology Clinical Research Unit Adelaide South Australia Recruiting
Peninsula & South Eastern Haematology and Oncology Group Frankston Victoria Recruiting
Cabrini Health Malvern Victoria Withdrawn
Linear Clinical Research Perth Western Australia Recruiting
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit Chisinau Moldova Recruiting
National Cancer Centre Singapore Singapore Singapore Recruiting
Tan Tock Seng Hospital Singapore Singapore Recruiting
Chungbuk National University Hospital Cheongju-si South Korea Recruiting
CHA Bundang Medical Center, CHA University Seongnam-si South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
The Catholic University of Korea St. Vincent's Hospital Suwon South Korea Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Taiwan Recruiting
National Cheng Kung University Hospital Tainan Taiwan Recruiting
Taipei Medical University - Shuang Ho Hospital Taipei Taiwan Recruiting
Taipei Veterans General Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05910827 on ClinicalTrials.gov ↗ ← All trials in South Korea