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NCT07003139
A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.
Phase 1/Phase 2 trial testing B10 L-BPA Injection in Malignant Brain Tumors in 10 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | China Medical University Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 30 June 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 2 locations across Taiwan |
Drugs / interventions tested
- B10 L-BPA Injection — full drug profile →
Conditions studied
- Malignant Brain Tumors — all drugs for Malignant Brain Tumors →
Sponsor
China Medical University Hospital
Who can join
18 and older, any sex, with Malignant Brain Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety of BNCT using B10 L-BPA in treating malignant brain tumors
Time frame: 6 months
Safety will be assessed by monitoring the occurrence, severity, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events and events leading to permanent discontinuation of therapy, according to protocol definitions and CTCAE v5.0. -
Efficacy of BNCT using B10 L-BPA in treating malignant brain tumors
Time frame: 6 months
Efficacy of BNCT with B10 L-BPA for treating malignant brain tumors will be assessed by the percentage of subjects achieving complete response (CR) and partial response (PR). Tumor response will be evaluated using RECIST v1.1 criteria via high-resolution CT or MRI.
Sponsor's own description
This Phase I/II study, titled 'A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07003139
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Malignant Brain Tumors
Currently open trials in the same condition.
- NCT07158710 — Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation · Phase 1 · recruiting
Other China Medical University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07003139 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Medical University Hospital
- Last refreshed: 11 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07003139.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing