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A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03433027
Recruitment Status : Active, not recruiting
First Posted : February 14, 2018
Last Update Posted : November 9, 2018
Information provided by (Responsible Party):
Benitec BioPharma Ltd

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: BB-401 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 12, 2019
Estimated Study Completion Date : October 19, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BB-401
BB-401 Intratumoral injection
Drug: BB-401
BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks

Primary Outcome Measures :
  1. Overall Response (OR) of the injected tumor [ Time Frame: 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 :
  1. Disease Control Rate (DCR) [ Time Frame: 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

  2. Progression Free Survival (PFS) [ Time Frame: 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

  3. Overall Survival (OS) [ Time Frame: 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

  4. Duration of Response (DoR) [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03433027

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Australia, New South Wales
The Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Australia, South Australia
Calvary Central Districts Hospital
Elizabeth Vale, South Australia, Australia
Russian Federation
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
Sponsors and Collaborators
Benitec BioPharma Ltd

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Responsible Party: Benitec BioPharma Ltd Identifier: NCT03433027     History of Changes
Other Study ID Numbers: BB-401-01
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6-8 weeks from data cut off/lock
Access Criteria: Data will only be available to the Data Safety Monitoring Board and Interim Analysis members

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site