Skip to main content
OpenTrials
Completed

NCT Number: NCT03433027

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BB-401

Drug

BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Benitec Biopharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.