Phase 12 Study of LMP744, a New Brain Cancer Drug, in Adults With Recurrent Glioblastoma

What this Trial Is About

Glioblastoma is a common and often fatal brain cancer in adults that frequently returns after standard treatments like surgery, radiation, and chemotherapy. Researchers are studying the drug LMP744, a novel indenoisoquinolone C-MYCTOPOISOMERASE 1 inhibitor, to see if it can kill tumor cells in people with recurrent glioblastoma. This open-label trial aims to evaluate the drugs effects and biological responses in adult patients whose glioblastoma has returned after prior treatment. Participants will first have a biopsy surgery to confirm recurrent glioblastoma and obtain baseline tissue samples. They will then receive LMP744 through a central line inserted into a vein in the chest for 5 consecutive days while staying in the clinic. After this, participants will undergo a second surgery to remove as much tumor as possible, with tissue, cerebrospinal fluid, and plasma collected for molecular analysis. Following recovery, participants will receive monthly 5-day cycles of LMP744 infusions for up to 12 months, along with blood tests, heart function tests, and imaging scans. During the study, participants will have imaging, heart function tests, and blood work to monitor their health and the drugs effects. They will complete quality of life questionnaires at various points. After finishing treatment, participants will have telehealth visits every 3 months for ongoing monitoring. The study will assess tumor response, progression-free survival, overall survival, molecular changes in tissue, and quality of life over a follow-up period of up to 5 years.

Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma