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

May 24, 2026 updated by: Hummingbird Bioscience

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Withdrawn
        • Genesiscare North Shore
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Rosemary Habib
        • Principal Investigator:
          • Rosemary Dr Habib
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Withdrawn
        • Icon Cancer Centre South Brisbane
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Greenslopes Private Hospital
        • Contact:
          • Rahul Ladwa
        • Principal Investigator:
          • Rahul Ladwa
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Southern Oncology Clinical Research Unit
        • Contact:
          • Ganessan Kichenadasse
        • Principal Investigator:
          • Ganessan Kichenadasse
    • Victoria
      • Frankston, Victoria, Australia
        • Recruiting
        • Peninsula & South Eastern Haematology and Oncology Group
        • Contact:
          • Vinod Ganju
        • Principal Investigator:
          • Vinod Prof Ganju
      • Malvern, Victoria, Australia, 3144
        • Withdrawn
        • Cabrini Health
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
        • Principal Investigator:
          • samantha bowyer
        • Contact:
          • Samantha Bowyer
  • Moldova
      • Chisinau, Moldova
        • Recruiting
        • The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
        • Contact:
          • Iurie Bulat
        • Principal Investigator:
          • Iurie Bulat
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
          • Aaron Tan
        • Principal Investigator:
          • Aaron Tan
      • Singapore, Singapore
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
          • Jens Samol
        • Principal Investigator:
          • Jens Samol
  • South Korea
      • Cheongju-si, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Principal Investigator:
          • Ki Hyeong Lee
        • Contact:
          • Ki Hyeong Lee
      • Seongnam-si, South Korea
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Principal Investigator:
          • Joo-Hang Kim
        • Contact:
          • Joo-Hang Kim
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital
        • Principal Investigator:
          • Hye Ryun Kim
        • Contact:
          • Hye Ryun Kim
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Yoon Ji Choi
        • Contact:
          • Yoon Ji Choi
      • Suwon, South Korea
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital
        • Contact:
          • Byoung Yong Shim
        • Principal Investigator:
          • Byoung Yong Shim
  • Taiwan
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Jen-Yu Hung
        • Contact:
          • Jen-Yu Hung
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Chun-Hui Lee
        • Principal Investigator:
          • Chun-Hui Lee
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Yung-Hung Lo
        • Principal Investigator:
          • Yung-Hung Lo
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital
        • Contact:
          • Wei-Hong Cheng
        • Principal Investigator:
          • Wei-Hong Cheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Participants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
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 or 60 mg/m IV once every 3 weeks
Experimental: Arm C
Participants receive HMBD-001 with 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: Cetuximab
Cetuximab 250 mg/m^2 weekly, with or without 400 mg/m^2 IV loading dose at C1D1
Experimental: Arm B
Participants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment.
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 or 60 mg/m IV once every 3 weeks
Drug: Cetuximab
Cetuximab 250 mg/m^2 weekly, with or without 400 mg/m^2 IV loading dose at C1D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
Number of participants with dose-limiting toxicities (DLTs) - applicable to part A
Time Frame: 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
From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)
Six months progression-free survival (PFS) - applicable to part B
Time Frame: 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
From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1
Time Frame: 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
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
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
HMBD-001 serum concentration-time profile and derived PK parameters
Time Frame: 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
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
HMBD-001 Immunogenicity Profile
Time Frame: 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
Number and percentage of participants who develop detectable ADAs
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hummingbird Bioscience

Collaborators

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMBD-001-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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