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ACTIVE NOT RECRUITING
NCT05919537
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

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

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

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