Back to resultsA Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BB-401
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma
Eligibility 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
Sites / Locations
- The Chris O'Brien Lifehouse
- Calvary Central Districts Hospital
- Irkutsk Oncology Center
- Clinical Oncology Dispensary #1
- Leningrad Regional Oncology Dispensary
- Saint Petersburg City Oncology Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BB-401
Arm Description
BB-401 Intratumoral injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Overall Survival (OS)
OS will be defined as the time from first treatment administration through to death due to any cause
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
Full Information
NCT ID
NCT03433027
First Posted
February 5, 2018
Last Updated
April 13, 2020
Sponsor
Benitec Biopharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03433027
Brief Title
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official Title
A Phase 2 Trial of Intratumoral EGFR Antisense DNA (BB-401) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) Who Have Failed All Available Standard Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
April 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benitec Biopharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BB-401
Arm Type
Experimental
Arm Description
BB-401 Intratumoral injection
Intervention Type
Drug
Intervention Name(s)
BB-401
Intervention Description
BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks
Primary Outcome Measure Information:
Title
Overall Response (OR) of the injected tumor
Description
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
Time Frame
Up to 20 months (estimated length of the study)
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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
Time Frame
End of Treatment Visit (Week 9) through to study end (up to 18 months)
Title
Progression Free Survival (PFS)
Description
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
Time Frame
Up to 20 months (estimated length of study)
Title
Overall Survival (OS)
Description
OS will be defined as the time from first treatment administration through to death due to any cause
Time Frame
Up to 20 months (estimated length of study)
Title
Duration of Response (DoR)
Description
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
Time Frame
20 months (estimated length of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Calvary Central Districts Hospital
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Irkutsk Oncology Center
City
Irkutsk
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary #1
City
Krasnodar
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Leningrad Region
Country
Russian Federation
Facility Name
Saint Petersburg City Oncology Clinic
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be available within 6-8 weeks from data cut off/lock
IPD Sharing Access Criteria
Data will only be available to the Data Safety Monitoring Board and Interim Analysis members
Learn more about this trial
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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