Trials / Not Yet Recruiting
Not Yet RecruitingNCT06797986
A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.
A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects with HPV Type 16 And/or 18 Positive Unresectable Recurrent or Metastatic Head
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- Sponsor
- Cellid Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.
Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- HPV (human Papillomavirus)-Associated Carcinoma
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BVAC-E6E7 (low level) | BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. |
| BIOLOGICAL | BVAC-E6E7 (high level) | BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. |
| BIOLOGICAL | BVAC-E6E7 (RP2D) | BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2025-01-29
- Last updated
- 2025-01-29
Source: ClinicalTrials.gov record NCT06797986. Inclusion in this directory is not an endorsement.