Trial 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
NCT ID:
NCT05919537
Condition:
Non-Small Cell Lung Cancer
Pancreatic Cancer
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Paclitaxel
Docetaxel
Gemcitabine
Conditions: Keywords:
HMBD-001
NRG1 fusion
NRG1
Neuregulin 1
ErbB3
HER3
Study type:
Interventional
Study phase:
Phase 1
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 IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV
weekly
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Arm group label:
Arm D
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel 75 mg/m^2 IV once every 3 weeks
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel 125 mg/m^2 IV on days 1, 8, 15, every 4 weeks
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine 1000 mg/m^2 IV on days 1, 8, 15, every 4 weeks
Arm group label:
Arm A
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.
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
- 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
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
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:
Recruiting
Contact:
Last name:
Vladimir Andelkovic
Investigator:
Last name:
Vladimir Andelkovic
Email:
Principal Investigator
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:
Cabrini Health
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gary Richardson
Investigator:
Last name:
Gary Richardson
Email:
Principal Investigator
Facility:
Name:
Linear Clinical Research
Address:
City:
Perth
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Michael Millward
Investigator:
Last name:
Michael Millward
Email:
Principal Investigator
Start date:
September 6, 2023
Completion date:
March 1, 2031
Lead sponsor:
Agency:
Hummingbird Bioscience
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/NCT05919537
