Trials / Recruiting
RecruitingNCT05910827
A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 398 (estimated)
- Sponsor
- Hummingbird Bioscience · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers
Conditions
- Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
- Advanced Head and Neck Squamous Cell Carcinoma
- Advanced Esophageal Squamous Cell Carcinoma
- Cervical Squamous Cell Carcinoma
- Advanced Cutaneous Squamous Cell Carcinoma
- Nasopharyngeal Cancinoma (NPC)
- Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HMBD-001 | HMBD-001 is a humanized Immunoglobulin G1 (IgG1) anti-Human Epidermal Growth Factor Receptor 3(HER3) monoclonal antibody (mAb). It is administered intravenously (IV) weekly |
| DRUG | Docetaxel | Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks |
| DRUG | Cetuximab | Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1 |
Timeline
- Start date
- 2024-02-05
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2023-06-20
- Last updated
- 2026-04-15
Locations
20 sites across 5 countries: Australia, Moldova, Singapore, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT05910827. Inclusion in this directory is not an endorsement.