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

Benitec Biopharma, Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

BB-401DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

The Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Calvary Central Districts Hospital

Elizabeth Vale, South Australia, Australia

Irkutsk Oncology Center

Irkutsk, Russia

Clinical Oncology Dispensary #1

Krasnodar, Russia

Outcomes

Primary Outcomes

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

Time frame: Up to 20 months (estimated length of the study)

Secondary Outcomes

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

Time frame: End of Treatment Visit (Week 9) through to study end (up to 18 months)

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

Time frame: 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

Time frame: 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

Time frame: 20 months (estimated length of study)

Data from ClinicalTrials.gov

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