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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06952868 | Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers | PHASE2 | RECRUITING | 24 | — | — | May 23, 2025 | Feb 28, 2027 | Jun 12, 2025 | 2 | Taiwan |
The objective response rate (ORR) of the B10 L-BPA-based BNCT, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the proportion of subjects whose best overall response is either complete response (CR) or partial response (PR) of the target lesions.
| Arm | Type | Description |
|---|---|---|
| Single arm treated by BNCT only | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Drug: B10 L-BPA Injection | DRUG | The investigational product is B10 L-BPA Injection, is a boron-containing compound in which 10B replaces a position on L-phenylalanine at the para position with dihydroxyboron. This single arm of the study is designed to evaluate the therapeutic efficacy of BNCT, wherein patients receive B10 L-BPA administration followed by neutron irradiation. |
Inclusion Criteria: 1. Subject aged 18-80 (inclusive). 2. Histologically or cytologically confirmed diagnosis of head and neck cancers with no distant metastasis in subjects as follows: 1. Unresectable recurrent or persistent squamous cell carcinoma (SCC) after completing one of the following f...