Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03433027 | A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | PHASE2 | COMPLETED | 16 | — | — | Mar 15, 2018 | Apr 6, 2020 | Apr 15, 2020 | 6 | Australia, Russia |
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
| Arm | Type | Description |
|---|---|---|
| BB-401 | EXPERIMENTAL | BB-401 Intratumoral injection |
| Name | Type | Description |
|---|---|---|
| BB-401 | DRUG | BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks |
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...