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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
Sponsor: Hummingbird Bioscience
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2023-09-06
Completion Date
2031-03-01
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly
Docetaxel
Docetaxel 75 mg/m\^2 IV once every 3 weeks
Nab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 IV on days 1, 8, 15, every 4 weeks
Gemcitabine
Gemcitabine 1000 mg/m\^2 IV on days 1, 8, 15, every 4 weeks
Locations (5)
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
Linear Clinical Research
Perth, Western Australia, Australia