Phase 01 Study of SGT-53 with Radiation and Nivolumab in Children and Young Adults with Recurrent or Progressive Brain Tumors

What this Trial Is About

Researchers are evaluating the use of the drug SGT-53 in combination with radiation therapy and the drug Nivolumab in children with brain tumors that have returned, worsened, or not improved after previous treatments. This early-phase clinical trial aims to find the right dose of SGT-53 that can be safely given alongside radiation and Nivolumab. The study also investigates the side effects of SGT-53, how the drug moves through the body, and how much of it reaches the tumor tissue in a small group of patients. During the first treatment cycle, participants receive SGT-53 twice a week, Nivolumab every two weeks, and radiation therapy during the second week. In cycles two through six, SGT-53 is given once a week during even cycles and twice a week during odd cycles, while Nivolumab continues every two weeks. From cycle seven onward, both SGT-53 and Nivolumab are given every two weeks. In a special early part of the study, four participants will have genetic testing on tumor samples after receiving SGT-53 to compare with skin samples. Participants will be closely monitored throughout the study with evaluations of side effects related to SGT-53 from enrollment to three years after treatment ends. Researchers will assess the drugs safety, how it is processed in the body, and its presence in tumor tissue. The study includes clinical and radiological assessments, genetic testing, and ongoing safety monitoring to understand the treatments effects over time.

A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.