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

Last updated: April 17, 2025
Sponsor: Hummingbird Bioscience
Overall Status: Active - Not Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Cancer

Pancreatitis

Treatment

Nab-paclitaxel

Gemcitabine

HMBD-001

Clinical Study ID

NCT05919537
HMBD-001-102
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 isresistant/refractory to standard systemic therapy, or for which there is nostandard systemic therapy or reasonable therapy in the physician's judgmentlikely to result in clinical benefit, or the participant has demonstrated to beintolerable to such therapy, or if such therapy has been refused by theparticipant

  • Arms A, B and C: Cancer harboring an NRG1 gene fusion with EGF-like domain; ArmA: Participants with locally advanced or metastatic pancreatic adenocarcinomathat have not received prior treatment with gemcitabine or nab-paclitaxel and /or have not received more than 2 lines of systemic therapy for advanceddisease; Arm B: Participants with locally advanced or metastatic non-small celllung cancer that have not received prior treatment with docetaxel and /or havenot 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 extracellulardomain.

  • Have an estimated life expectancy of at least 3 months

  • Have an archival tumour sample available or have a site of disease amenable tobiopsy and be willing to undergo a biopsy prior to the receipt of the assignedstudy treatment

  • Have adequate organ function

  • Females must be non-pregnant and non-lactating, willing to use a highlyeffective method of contraception from screening until study completion or beeither surgically sterile or post-menopausal

  • Males must be surgically sterile, abstinent, or if engaged in sexual relationswith a woman of child-bearing potential, the participant and his partner mustbe surgically sterile or using an acceptable, highly effective contraceptivemethod from screening until study completion

Exclusion

Exclusion Criteria:

  • Prior treatment with HMBD-001, pertuzumab, or an agent that specifically targetsHER3, including pan-HER tyrosine kinase inhibitors

  • Persistent clinically significant toxicities (Grade ≥2) from previousanti-cancer therapy except for Grade >2 toxicities that are considered unlikelyto put the participant at an increased risk of treatment-related toxicityand/or impact the study results e.g., alopecia

  • Most recent anti-cancer therapy including radiotherapy at least 4 weeks, ornitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever isshorter prior to starting the assigned study treatment

  • Symptomatic primary Central Nervous System (CNS) cancer or metastases unlessthe symptoms are stable for at least 28 days prior to the first dose of thestudy drug and any symptoms have returned to baseline

  • Evidence of abnormal cardiac function

  • History of uncontrolled allergic reactions and/or known expectedhypersensitivity to the study drugs used in the treatment arm to which theparticipant is to be enrolled into

  • Any other known active malignancy except for treated cervical intraepithelialneoplasia, or non-melanoma skin cancer

  • Any uncontrolled illness or significant uncontrolled condition(s) requiringsystemic 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

Total Participants: 68
Treatment Group(s): 4
Primary Treatment: Nab-paclitaxel
Phase: 1
Study Start date:
September 06, 2023
Estimated Completion Date:
March 01, 2031

Connect with a study center

  • GenesisCare North Shore

    Sydney, New South Wales 2065
    Australia

    Site Not Available

  • ICON Cancer Centre South Brisbane

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia 5042
    Australia

    Site Not Available

  • Cabrini Health

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Linear Clinical Research

    Perth, Western Australia 6009
    Australia

    Site Not Available

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