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

Phase 2
Completed
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Drug: BB-401
Registration Number
NCT03433027
Lead Sponsor
Benitec Biopharma, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
BB-401BB-401BB-401 Intratumoral injection
Primary Outcome Measures
NameTimeMethod
Overall Response (OR) of the injected tumorUp 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
NameTimeMethod
Overall Survival (OS)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

Duration of Response (DoR)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

Disease Control Rate (DCR)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

Progression Free Survival (PFS)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

Trial Locations

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, 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

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