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

Benitec BioPharma

Status and phase: Completed; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: BB-401

Study type: Interventional

Funder types: Industry

Identifiers

NCT03433027

BB-401-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

BB-401

Experimental group

Description:

BB-401 Intratumoral injection

Treatment:

Drug: BB-401