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The study will investigate the safety and optimal dose of NBTXR3 for non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent).
The study has a two-cohort, open-label design consisting of two parts: (i) RT safety lead-in cohort (n=10) and NBTXR3 activated by RT dose-finding cohort (n=12); and (ii) expansion at the recommended Phase 2 dose with toxicity (n=12).
The dose levels to be explored are 22% and 33% of baseline gross tumor volume. The planned enrollment period is up to three years.
The Phase 1 trial is among five collaborator-led studies active and recruiting at The University of Texas MD Anderson Cancer Center. The third is to enroll its first patient.
NBTXR3 comprises functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy.
Price Action: NBTX shares closed at $13.78 on Wednesday.
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