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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05919537




Registration number
NCT05919537
Ethics application status
Date submitted
1/06/2023
Date registered
26/06/2023
Date last updated
24/01/2024

Titles & IDs
Public title
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
Scientific title
A Phase 1b Study to Evaluate HMBD-001 With or Without Chemotherapy in Participants With Advanced Solid Tumors Harboring NRG1 Gene Fusions or Selected HER3 Mutations
Secondary ID [1] 0 0
HMBD-001-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Pancreatic Cancer 0 0
Locally Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Condition category
Condition code

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

Experimental: Arm A - Participants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) harboring NRG1 gene fusions

Experimental: Arm B - Participants with non-small cell lung cancer (NSCLC) harboring NRG1 gene fusions

Experimental: Arm C - Participants with other solid tumors harboring NRG1 gene fusions

Experimental: Arm D - Participants with solid tumors harboring selected HER3 extracellular mutations


Treatment: Drugs: HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly

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

Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 IV on days 1, 8, 15, every 4 weeks

Treatment: Drugs: Gemcitabine
Gemcitabine 1000 mg/m\^2 IV on days 1, 8, 15, every 4 weeks
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 ICF is signed until 30 days after last dose of study treatment
Primary outcome [2] 0 0
Arm A and B only: Incidence and nature of dose-limiting toxicities (DLTs) during the first cycle of treatment
Timepoint [2] 0 0
Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study treatment
Primary outcome [3] 0 0
Objective Response Rate (ORR) by 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
* Histologic or cytologic evidence of an advanced malignant solid that is resistant/refractory to standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the physician's judgment likely to result in clinical benefit, or the participant has demonstrated to be intolerable to such therapy, or if such therapy has been refused by the participant
* Arms A, B and C: Cancer harboring an NRG1 gene fusion with EGF-like domain; Arm A: Participants with locally advanced or metastatic pancreatic adenocarcinoma that have not received prior treatment with gemcitabine or nab-paclitaxel and /or have not received more than 2 lines of systemic therapy for advanced disease; Arm B: Participants with locally advanced or metastatic non-small cell lung cancer that have not received prior treatment with docetaxel and /or have not received more than 2 lines of systemic therapy for advanced disease; Arm C: Participants must not be eligible to participate in Arm A or B
* Arm D: Cancer harboring selected HER3 mutations limited to the extracellular domain.
* Have an estimated life expectancy of at least 3 months
* Have an archival tumour sample available or have a site of disease amenable to biopsy and be willing to undergo a biopsy prior to the receipt of the assigned study treatment
* 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, pertuzumab, or an agent that specifically targets HER3, including pan-HER tyrosine kinase inhibitors

* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
6/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
68
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
Cabrini Health - Malvern
Recruitment hospital [5] 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
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hummingbird Bioscience
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 1b multi-center, open-label study of HMBD-001 with or without chemotherapy in participants with advanced solid tumors harboring NRG1 gene fusions or selected HER3 mutations.
Trial website
https://clinicaltrials.gov/study/NCT05919537
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
+6569795574
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05919537