Status:
COMPLETED
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Benitec Biopharma, Inc.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 metast...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03433027
Start Date
March 15 2018
End Date
April 6 2020
Last Update
April 15 2020
Active Locations (6)
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1
The Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
2
Calvary Central Districts Hospital
Elizabeth Vale, South Australia, Australia
3
Irkutsk Oncology Center
Irkutsk, Russia
4
Clinical Oncology Dispensary #1
Krasnodar, Russia