A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Drug: BB-401
- Registration Number
- NCT03433027
- Lead Sponsor
- Benitec Biopharma, Inc.
- 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 metastatic/recurrent HNSCC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BB-401 BB-401 BB-401 Intratumoral injection
- Primary Outcome Measures
Name Time Method Overall Response (OR) of the injected tumor Up to 20 months (estimated length of the study) Overall response is defined as Complete Response (CR) or Partial Response (PR) as evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee version 1.1
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to 20 months (estimated length of study) OS will be defined as the time from first treatment administration through to death due to any cause
Duration of Response (DoR) 20 months (estimated length of study) DoR assessments will be performed on the subset of patients for who a CR, PR, or SD response is achieved. DoR will be measured from the time where the response criteria are first met, until the first date that progressive disease is objectively documented, or the date of death due to any cause
Disease Control Rate (DCR) End of Treatment Visit (Week 9) through to study end (up to 18 months) DCR is measured on a subset of subjects who achieve Stable Disease (SD), Partial Response (PR) or Complete Response (CR) at the End of Treatment visit. DCR will be defined as the proportion of these subjects that show absence of disease progression as evaluated using the RECIST v1.1 criteria
Progression Free Survival (PFS) Up to 20 months (estimated length of study) PFS will be defined as the time from first treatment administration to first observation of documented disease progression as evaluated using the RECIST v1.1 criteria
Trial Locations
- Locations (6)
The Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Calvary Central Districts Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Irkutsk Oncology Center
🇷🇺Irkutsk, Russian Federation
Clinical Oncology Dispensary #1
🇷🇺Krasnodar, Russian Federation
Leningrad Regional Oncology Dispensary
🇷🇺Leningrad Region, Russian Federation
Saint Petersburg City Oncology Clinic
🇷🇺Saint Petersburg, Russian Federation