biostudies-literatureUnknown6(1)Carrillo JNascent Biotech<h4>Background</h4>This phase 1 (NCT04396717) open-label, multicenter study, evaluated Pritumumab, a IgG1 monoclonal antibody, in patients with gliomas and brain metastases. The primary objective was to evaluate the safety and/or tolerability and to identify a recommended phase 2 dose (RP2D) of Pritumumab.<h4>Methods</h4>Adult patients with recurrent gliomas or brain metastases were enrolled in the dose cohort that was open at the time of their consent. Study treatment consisted of pritumumab administered intravenously weekly on days 1, 8, 15, and 22 in 28-day cycles. Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated.<h4>Results</h4>Fifteen patients received Pritumumab in the recurrent setting. Pritumumab was well tolerated, with no serious adverse Neuro-oncology advancesvdae166https://www.ebi.ac.uk/biostudies/studies/S-EPMC11502913biostudies-literatureA phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases.PMC11502913Babic INomura NKesari SCarrick SShah DKCarrillo JGill JMRedfern CfalseA phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases.<h4>Background</h4>This phase 1 (NCT04396717) open-label, multicenter study, evaluated Pritumumab, a IgG1 monoclonal antibody, in patients with gliomas and brain metastases. The primary objective was to evaluate the safety and/or tolerability and to identify a recommended phase 2 dose (RP2D) of Pritumumab.<h4>Methods</h4>Adult patients with recurrent gliomas or brain metastases were enrolled in the dose cohort that was open at the time of their consent. Study treatment consisted of pritumumab administered intravenously weekly on days 1, 8, 15, and 22 in 28-day cycles. Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated.<h4>Results</h4>Fifteen patients received Pritumumab in the recurrent setting. Pritumumab was well tolerated, with no serious adverse 2024-01-01T00:00:00Z2024 Jan-Dec2026-07-15T17:49:11.627Z2025-04-04T02:58:57.521ZS-EPMC115029133946521710.1093/noajnl/vdae166