Phase
Condition
Non-small Cell Lung Cancer
Cancer
Pancreatitis
Treatment
Nab-paclitaxel
Gemcitabine
HMBD-001
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
GenesisCare North Shore
Sydney, New South Wales 2065
AustraliaSite Not Available
ICON Cancer Centre South Brisbane
Brisbane, Queensland 4101
AustraliaSite Not Available
Southern Oncology Clinical Research Unit
Adelaide, South Australia 5042
AustraliaSite Not Available
Cabrini Health
Malvern, Victoria 3144
AustraliaSite Not Available
Linear Clinical Research
Perth, Western Australia 6009
AustraliaSite Not Available
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