Liposomal curcumin (LC) + RT/TMZ hits RP2D 350mg/m² with early survival signal in newly diagnosed IDH-wt GBM

Liposomal curcumin (LC) is an IV nano/liposomal curcumin formulation intended to improve curcumin exposure and modulate inflammatory/oxidative and oncogenic signaling (including kynurenine-pathway biology) alongside standard radiotherapy + temozolomide (RT/TMZ) for newly diagnosed high-grade glioma. In this open-label Phase I/II, TITE-BOIN dose-escalation study (NCT05768919), 25 patients with newly diagnosed WHO grade 4 glioblastoma/molecular glioblastoma, IDH-wildtype (median age 56; median KPS 90; MGMT: 7 methylated, 17 unmethylated, 1 indeterminate) received weekly LC (planned 34 doses) with standard RT (60Gy in 30 fractions) and concomitant TMZ, then adjuvant TMZ; two DLTs at 400mg/m² (grade 4 pancytopenia; grade 1 hemolysis) led to selection of 350mg/m² as RP2D, with LC-related grade ≥3 AEs in 16% and no LC-related deaths. With median follow-up 12.9 months (data cutoff 1/23/2026), median PFS/OS were not reached and 6- and 12-month overall survival rates were 95% and 87% among uncensored patients (n=18 and n=13), which looks directionally higher than historical Stupp-regimen benchmarks (median OS ~14.6 months; median PFS ~6.9 months) and is particularly notable given the high proportion of MGMT-unmethylated tumors, where outcomes are typically worse (often ~11–12 months median OS in large real-world datasets).