TerminatedPhase 1/2

Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas

Stopped: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.

South Korea7 participantsStarted 2022-12-05

Plain-language summary

This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas. The Phase I clinical study is to explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas and characterize the safety, efficacy and pharmacokinetics. To evaluate the primary objective of tolerability, subject population with history of exposure to a similar treatment recurrent high-grade glioma who received prior standard radiotherapy will be recruited. The Phase IIa is to confirm the efficacy and safety after irradiation of radiation dose confirmed in the Phase I clinical study. To evaluate the primary objective of efficacy, subject population with glioblastoma (The 2021 WHO Classification of Tumors of the Central Nervous System, Glioblastoma IDH-wild type, WHO Grade 4) will be recruited.

Who can participate

Age range19 Years – 80 Years

SexALL

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Inclusion criteria

✓. An adult at the age 19 or above to under 80 at the time of written consent
✓. Individual diagnosed with the following according to the WHO classification (2021)
✓. Individual who received radiation therapy at the standard level (54 to 66 Gy/25 to 35 fractions) or lower
✓. Individual confirmed to have disease progression\* according to the RANO criteria within 4 weeks from the screening visit (\*) At least one lesion with contrast enhancement needs to exist on the contrast enhancement MRI. For a subject who shows no lesion with contrast enhancement, functional imaging such as 18F-FET or 18F-FDOPA PET/CT needs to confirm the existence of at least one clear recurrent lesion.
✓. Individual who is able to lie or sit for 30 minutes to 1 hour using the fixing device of the treatment couch
✓. Individual with no metal implant such as a pacemaker
✓. Individual with KPS (Karnofsky performance score) ≥ 60
✓. Individual with an appropriate kidney function, lung function and bone marrow function based on the laboratory test at the screening visit

Exclusion criteria

What they're measuring

Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT

Timeframe: During 90 days post-BNCT

Phase IIa: Proportion of 6-month PFS evaluated by central imaging according to the modified RANO criteria

Timeframe: 6 months

Trial details

NCT IDNCT05737212

SponsorDawonmedax Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-11

View on ClinicalTrials.gov More Recurrent High-grade Glioma trials