Trial Title:
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
NCT ID:
NCT05910827
Condition:
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Advanced Head and Neck Squamous Cell Carcinoma
Advanced Esophageal Squamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Advanced Cutaneous Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Neoplasms, Squamous Cell
Docetaxel
Cetuximab
Conditions: Keywords:
NSCLC
Non-small Cell Lung Cancer
sqNSCLC
Lung
Squamous
HER3
ErbB3
Docetaxel
Cetuximab
cervical squamous cell carcinoma
HNSCC
CSCC
ESCC
advanced squamous cell cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HMBD-001
Description:
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
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel 75 mg/m^2 or 60 mg/m IV once every 3 weeks
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab 400 mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
Arm group label:
Arm B
Arm group label:
Arm C
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
Criteria for eligibility:
Criteria:
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 or cervical SCC
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GenesisCare North Shore
Address:
City:
Sydney
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nick Pavlakis
Investigator:
Last name:
Nick Pavlakis
Email:
Principal Investigator
Facility:
Name:
ICON Cancer Centre South Brisbane
Address:
City:
Brisbane
Zip:
4101
Country:
Australia
Status:
Withdrawn
Facility:
Name:
Southern Oncology Clinical Research Unit
Address:
City:
Adelaide
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Ganessan Kichenadasse
Investigator:
Last name:
Ganessan Kichenadasse
Email:
Principal Investigator
Facility:
Name:
Peninsula & South Eastern Haematology and Oncology Group
Address:
City:
Frankston
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Vinod Ganju
Investigator:
Last name:
Vinod Prof Ganju
Email:
Principal Investigator
Facility:
Name:
Cabrini Health
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Withdrawn
Facility:
Name:
Linear Clinical Research
Address:
City:
Perth
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Samantha Bowyer
Investigator:
Last name:
Samantha Bowyer
Email:
Principal Investigator
Facility:
Name:
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Address:
City:
Chisinau
Country:
Moldova, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Iurie Bulat
Investigator:
Last name:
Iurie Bulat
Email:
Principal Investigator
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Aaron Tan
Investigator:
Last name:
Aaron Tan
Email:
Principal Investigator
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Jens Samol
Investigator:
Last name:
Jens Samol
Email:
Principal Investigator
Start date:
February 5, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Hummingbird Bioscience
Agency class:
Industry
Collaborator:
Agency:
Merck KGaA, Darmstadt, Germany
Agency class:
Industry
Source:
Hummingbird Bioscience
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910827
