A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 Trial of Intratumoral EGFR Antisense DNA (BB-401) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) Who Have Failed All Available Standard Therapies
Lead SponsorBenitec Ltd
StatusCompleted No Results Posted
Indication/ConditionHead and Neck Squamous Cell Carcinoma
The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.
Key Inclusion Criteria: Histologically or cytologically confirmed HNSCC Failed (or are ineligible/decline to receive) all available standard therapies Stable, treated brain metastases One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection Eastern Cooperative Oncology Group (ECOG) 0-2 Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy Key Exclusion Criteria: Nasopharyngeal Carcinoma Concomitant anti-cancer therapy Unresolved toxicities from prior treatments Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation