A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas
1 other identifier
interventional
398
5 countries
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2024
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 20, 2023
CompletedStudy Start
First participant enrolled
February 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 15, 2026
April 1, 2026
3.8 years
June 1, 2023
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
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 Outcomes (3)
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1
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
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
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
Study Arms (3)
Arm A
EXPERIMENTALParticipants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
Arm B
EXPERIMENTALParticipants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment.
Arm C
EXPERIMENTALParticipants receive HMBD-001 with cetuximab
Interventions
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
Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hummingbird Biosciencelead
- Merck KGaA, Darmstadt, Germanycollaborator
Study Sites (20)
GenesisCare North Shore
Sydney, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
ICON Cancer Centre South Brisbane
Brisbane, Queensland, 4101, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, 5042, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Cabrini Health
Malvern, Victoria, 3144, Australia
Linear Clinical Research
Perth, Western Australia, 6009, Australia
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
National Cancer Centre Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Chungbuk National University Hospital
Cheongju-si, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 20, 2023
Study Start
February 5, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share