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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly
Docetaxel 75 mg/m\^2 IV once every 3 weeks
Nab-paclitaxel 125 mg/m\^2 IV on days 1, 8, 15, every 4 weeks
GenesisCare North Shore
Sydney, New South Wales, Australia
ICON Cancer Centre South Brisbane
Brisbane, Queensland, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Cabrini Health
Malvern, Victoria, Australia
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.
Time frame: From the time the ICF is signed until 30 days after last dose of study treatment
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
Time frame: Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study treatment
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
Time frame: Up to 24 months
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Gemcitabine 1000 mg/m\^2 IV on days 1, 8, 15, every 4 weeks
Linear Clinical Research
Perth, Western Australia, Australia