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BB-401

Phase 2

Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Benitec Biopharma Inc.|Last Updated: Apr 15, 2020

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical trial landscape

BB-401 · 1 trial · 1 indication

Phase 2 1
NCT03433027A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma
COMPLETED16 Analytics
PHASE2COMPLETED
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
NCT0343302716
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Study Endpoints
Primary Endpoints
Overall Response (OR) of the injected tumor
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 Endpoints
Disease Control Rate (DCR)
End of Treatment Visit (Week 9) through to study end (up to 18 months)
Progression Free Survival (PFS)
Up to 20 months (estimated length of study)
Overall Survival (OS)
Up to 20 months (estimated length of study)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BB-401EXPERIMENTALBB-401 Intratumoral injection
Interventions
NameTypeDescription
BB-401DRUGBB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 sui...

Countries:AustraliaRussia
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