Trial | NCT03433027  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    BB-401

  • Study Participants

    16
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.
Study Started
Mar 15
2018
Primary Completion
Dec 12
2018
Study Completion
Apr 06
2020
Last Update
Apr 15
2020

Drug BB-401

BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks

BB-401 Experimental

BB-401 Intratumoral injection

Criteria 

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
No Results Posted