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Non-Small Cell Lung CancerPhase 1NCT05919537

Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation

A Phase 1 study testing HMBD-001, Docetaxel and Nab-paclitaxel in people with Non-Small Cell Lung Cancer and Pancreatic Cancer, run by Hummingbird Bioscience at 5 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HMBD-001, Docetaxel and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
5 sitesAustralia
Study dates
6 Sep 2023to 1 Mar 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia, 5042

  • ICON Cancer Centre South Brisbane

    Brisbane, Queensland, 4101

  • Cabrini Health

    Malvern, Victoria, 3144

  • Linear Clinical Research

    Perth, Western Australia, 6009

  • GenesisCare North Shore

    Sydney, New South Wales, 2065

Other trials in Australia

About this study

Official 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

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.

Being tested
HMBD-001, Docetaxel, Nab-paclitaxel, Gemcitabine
Keywords
HMBD-001, NRG1 fusion, NRG1, Neuregulin 1, ErbB3, HER3
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Neoplasm Metastasis, Fibromatosis, Gingival, 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMBD-001Drug

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

  • DocetaxelDrug

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

  • Nab-paclitaxelDrug

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

  • GemcitabineDrug

    Gemcitabine 1000 mg/m^2 IV on days 1, 8, 15, every 4 weeks

Study groups in NCT05919537
Study groupRoleWhat they receive
Arm AExperimentalParticipants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) harboring NRG1 gene fusions
Receives: Drug: HMBD-001; Drug: Nab-paclitaxel; Drug: Gemcitabine
Arm BExperimentalParticipants with non-small cell lung cancer (NSCLC) harboring NRG1 gene fusions
Receives: Drug: HMBD-001; Drug: Docetaxel
Arm CExperimentalParticipants with other solid tumors harboring NRG1 gene fusions
Receives: Drug: HMBD-001
Arm DExperimentalParticipants with solid tumors harboring selected HER3 extracellular mutations
Receives: Drug: HMBD-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Nature of Adverse Events (AEs)

    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.

    Measured: From the time the ICF is signed until 30 days after last dose of study treatment

  2. Arm A and B only: Incidence and nature of dose-limiting toxicities (DLTs) during the first cycle of treatment

    DLTs will be assessed during the safety run-in phase 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 (4 weeks for Arm A, 3 weeks for Arm B) of treatment

    Measured: Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study treatment

  3. Objective Response Rate (ORR) by RECIST V1.1

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start6 Sep 2023
  3. Primary completion1 Mar 2031 (estimated)
  4. Study completion1 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919537
Sponsor's protocol ID
HMBD-001-102
Status last verified
Apr 2025
First submitted
1 Jun 2023
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMBD-001, Docetaxel and Nab-paclitaxel in people with Non-Small Cell Lung Cancer and Pancreatic Cancer, run by Hummingbird Bioscience at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Nature of Adverse Events (AEs) (time frame: From the time the ICF is signed until 30 days after last dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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Clinical Trial NCT05919537 | AzTrials