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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BB-401 | Experimental | BB-401 Intratumoral injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BB-401 | Drug | BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR) of the injected tumor | 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 | Up to 20 months (estimated length of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | 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 | End of Treatment Visit (Week 9) through to study end (up to 18 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chris O'Brien Lifehouse | Camperdown | New South Wales | Australia | |||
| Calvary Central Districts Hospital |
De-identified individual participant data for primary and secondary outcome measures will be made available for the Interim Analysis and routinely through-out the study for the Data Safety Monitoring Board
Data will be available within 6-8 weeks from data cut off/lock
Data will only be available to the Data Safety Monitoring Board and Interim Analysis members
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Progression Free Survival (PFS) | 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 | Up to 20 months (estimated length of study) |
| Overall Survival (OS) | OS will be defined as the time from first treatment administration through to death due to any cause | Up to 20 months (estimated length of study) |
| Duration of Response (DoR) | 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 | 20 months (estimated length of study) |
| Elizabeth Vale |
| South Australia |
| Australia |
| Irkutsk Oncology Center | Irkutsk | Russia |
| Clinical Oncology Dispensary #1 | Krasnodar | Russia |
| Leningrad Regional Oncology Dispensary | Leningrad Region | Russia |
| Saint Petersburg City Oncology Clinic | Saint Petersburg | Russia |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |