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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433027
• Other study ID #: BB-401-01
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2018
• Est. completion date: April 6, 2020

Study information

• Verified date: April 2020
• Source: Benitec BioPharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 6, 2020
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
Australia	The Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Calvary Central Districts Hospital	Elizabeth Vale	South 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

Sponsors (1)

Lead Sponsor	Collaborator
Benitec BioPharma Ltd

Countries where clinical trial is conducted

Australia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 20 months (estimated length of the study)
Secondary	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	End of Treatment Visit (Week 9) through to study end (up to 18 months)
Secondary	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	Up to 20 months (estimated length of study)
Secondary	Overall Survival (OS)	OS will be defined as the time from first treatment administration through to death due to any cause	Up to 20 months (estimated length of study)
Secondary	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	20 months (estimated length of study)