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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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Frequently asked questions about BB-401

What is BB-401 used for in Head and Neck Squamous Cell Carcinoma?

BB-401 is an investigational small molecule being studied for the treatment of recurrent or metastatic Head and Neck Squamous Cell Carcinoma. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes BB-401?

BB-401 is being developed by Benitec Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol BNTC. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is BB-401 in?

BB-401 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an uncontrolled, non-randomized study involving 16 participants with recurrent or metastatic Head and Neck Squamous Cell Carcinoma. The drug remains investigational and is not FDA approved.

What clinical trials is BB-401 in?

BB-401 has been studied in one clinical trial with the identifier NCT03433027, titled 'A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.' This Phase 2 trial was completed and enrolled 16 participants in Australia and Russia.

Is BB-401 the same as any other drug?

No alternative names for BB-401 have been identified. The drug is referred to solely as BB-401 in clinical and regulatory contexts, and it is being developed by Benitec Biopharma Inc. for the treatment of Head and Neck Squamous Cell Carcinoma.