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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05910827




Registration number
NCT05910827
Ethics application status
Date submitted
1/06/2023
Date registered
20/06/2023
Date last updated
25/04/2024

Titles & IDs
Public title
Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers
Scientific title
A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-small Cell Lung Cancers
Secondary ID [1] 0 0
HMBD-001-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMBD-001
Treatment: Drugs - Docetaxel
Treatment: Drugs - Cetuximab

Experimental: Arm A - All participants receive HMBD-001 with docetaxel

Experimental: Arm B - All participants receive HMBD-001 with docetaxel plus cetuximab


Treatment: Drugs: 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

Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m^2 IV once every 3 weeks

Treatment: Drugs: Cetuximab
Cetuximab 400 mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Nature of Adverse Events (AEs)
Timepoint [1] 0 0
From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
Primary outcome [2] 0 0
Number of participants with dose-limiting toxicities (DLTs)
Timepoint [2] 0 0
During the first three weeks of study treatment
Primary outcome [3] 0 0
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1
Timepoint [3] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
- Ability to understand and be willing to sign an informed consent form

- Males and females aged over 18 years

- Eastern Cooperative Oncology Group (ECOG) status of 0 to 1

- 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

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GenesisCare North Shore - Sydney
Recruitment hospital [2] 0 0
ICON Cancer Centre South Brisbane - Brisbane
Recruitment hospital [3] 0 0
Southern Oncology Clinical Research Unit - Adelaide
Recruitment hospital [4] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [5] 0 0
Cabrini Health - Malvern
Recruitment hospital [6] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
5042 - Adelaide
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hummingbird Bioscience
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05910827
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kon Yew Kwek, BMBCh, DPhil
Address 0 0
Country 0 0
Phone 0 0
+65 6979 5574
Fax 0 0
Email 0 0
k.y.kwek@hummingbirdbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05910827