NCT05919537

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Hummingbird Bioscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Locally Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-06
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2023-06-26
• Last updated: 2025-04-18

Locations

5 sites across 1 country: Australia