A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2020-04-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benitec BioPharma Ltd

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