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

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ClinicalTrials.gov Identifier: NCT05919537
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Hummingbird Bioscience

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Pancreatic Cancer Locally Advanced Solid Tumor Metastatic Solid Tumor Drug: HMBD-001 Drug: Docetaxel Drug: Nab-paclitaxel Drug: Gemcitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 6, 2023
Estimated Primary Completion Date : March 1, 2031
Estimated Study Completion Date : March 1, 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Participants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) harboring NRG1 gene fusions
 Drug: HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly

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

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 IV on days 1, 8, 15, every 4 weeks
Experimental: Arm B
Participants with non-small cell lung cancer (NSCLC) harboring NRG1 gene fusions
 Drug: HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly

Drug: Docetaxel
Docetaxel 75 mg/m^2 IV once every 3 weeks
Experimental: Arm C
Participants with other solid tumors harboring NRG1 gene fusions
 Drug: HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly
Experimental: Arm D
Participants with solid tumors harboring selected HER3 extracellular mutations
 Drug: HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. Arm A and B only: Incidence and nature of dose-limiting toxicities (DLTs) during the first cycle of treatment [ Time Frame: Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study 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

  3. Objective Response Rate (ORR) by RECIST V1.1 [ Time Frame: Up to 24 months ]
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919537


Contacts
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Contact: Kon Yew Kwek, BMBCh, DPhil +6569795574 k.y.kwek@hummingbirdbio.com

Locations
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Australia, New South Wales
GenesisCare North Shore Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Nick Pavlakis         
Principal Investigator: Nick Pavlakis         
Australia, Queensland
ICON Cancer Centre South Brisbane Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Vladimir Andelkovic         
Principal Investigator: Vladimir Andelkovic         
Australia, South Australia
Southern Oncology Clinical Research Unit Recruiting
Adelaide, South Australia, Australia, 5042
Contact: Ganessan Kichenadasse         
Principal Investigator: Ganessan Kichenadasse         
Australia, Victoria
Cabrini Health Recruiting
Malvern, Victoria, Australia, 3144
Contact: Gary Richardson         
Principal Investigator: Gary Richardson         
Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia, 6009
Contact: Michael Millward         
Principal Investigator: Michael Millward         
Sponsors and Collaborators
Hummingbird Bioscience
More Information
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Responsible Party: Hummingbird Bioscience
ClinicalTrials.gov Identifier: NCT05919537    
Other Study ID Numbers: HMBD-001-102
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hummingbird Bioscience:
HMBD-001
NRG1 fusion
NRG1
 Neuregulin 1
ErbB3
HER3
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Docetaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites