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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

NCT05919537 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-04-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hummingbird Bioscience

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2031-03-01
Completion
2031-03-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919537 on ClinicalTrials.gov