A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Docetaxel: Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
Cetuximab: Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1
Study 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
Eligibility
Primary outcome measure(s)
- Incidence and Nature of Adverse Events (AEs) — From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, vital signs and ECG results per NCI CTCAE V5.0 Incidence of dose interruptions and modifications An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment - Number of participants with dose-limiting toxicities (DLTs) - applicable to part A — From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)
DLTs will be assessed in the dose escalation cohorts and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment - Six months progression-free survival (PFS) - applicable to part B — From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months
Number of participants achieving progression-free survival (PFS) at 6 months
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| GenesisCare North Shore | Sydney | New South Wales | Withdrawn |
| Westmead Hospital | Westmead | New South Wales | Recruiting |
| ICON Cancer Centre South Brisbane | Brisbane | Queensland | Withdrawn |
| Greenslopes Private Hospital | Greenslopes | Queensland | Recruiting |
| Southern Oncology Clinical Research Unit | Adelaide | South Australia | Recruiting |
| Peninsula & South Eastern Haematology and Oncology Group | Frankston | Victoria | Recruiting |
| Cabrini Health | Malvern | Victoria | Withdrawn |
| Linear Clinical Research | Perth | Western Australia | Recruiting |
| The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit | Chisinau | Moldova | Recruiting |
| National Cancer Centre Singapore | Singapore | Singapore | Recruiting |
| Tan Tock Seng Hospital | Singapore | Singapore | Recruiting |
| Chungbuk National University Hospital | Cheongju-si | South Korea | Recruiting |
| CHA Bundang Medical Center, CHA University | Seongnam-si | South Korea | Recruiting |
| Korea University Anam Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | South Korea | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan | Recruiting |
| National Cheng Kung University Hospital | Tainan | Taiwan | Recruiting |
| Taipei Medical University - Shuang Ho Hospital | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei | Taiwan | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05910827 on ClinicalTrials.gov ↗ ← All trials in South Korea