Clinical trial · Interventional
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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
NCT03433027CI-TRIAL-00044663completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BB-401 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BB-401
- description
- BB-401 Intratumoral injection
- interventionNames
- Drug: BB-401
Primary outcomes (1)
- measure
- Overall Response (OR) of the injected tumor
- timeFrame
- Up to 20 months (estimated length of the study)
- description
- 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 outcomes (4)
- measure
- Disease Control Rate (DCR)
- timeFrame
- End of Treatment Visit (Week 9) through to study end (up to 18 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.