Head and Neck Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGBB-401
BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks
Sponsors
Benitec Biopharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Australia, Russia
Outcome results
None listed