A phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases.

ABSTRACT:

Background

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.

Methods

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.

Results

Fifteen patients received Pritumumab in the recurrent setting. Pritumumab was well tolerated, with no serious adverse

SUBMITTER: Carrillo J 

PROVIDER: S-EPMC11502913 | biostudies-literature | 2024 Jan-Dec

REPOSITORIES: biostudies-literature