Phase 12 Study of CBL0137 Infusion for Children and Young Adults with Relapsed or Refractory Solid Tumors, CNS Tumors, and Lymphoma

What this Trial Is About

Researchers are studying CBL0137, an experimental drug given intravenously, to find the best dose, side effects, and possible benefits for children and young adults aged 1 year to 21 years with relapsed or refractory solid tumors, including central nervous system tumors, lymphoma, and specific brain tumors like diffuse intrinsic pontine glioma DIPG and other H3 K27-altered diffuse midline gliomas DMG. This phase III trial aims to estimate the maximum tolerated dose and assess the drugs anti-tumor effects and safety in these patients. Participants receive CBL0137 by intravenous infusion over 30 minutes on days 1 and 8 of each 21-day cycle, for up to 17 cycles if their disease does not progress or they do not experience unacceptable side effects. Patients may continue treatment despite pseudoprogression if their doctor agrees. Alongside treatment, patients undergo echocardiograms and blood sample collections regularly, and may have bone marrow aspirates or biopsies if needed. During the study, researchers monitor treatment effects through scans, blood tests, heart function tests, and biological markers in tumor and blood samples. Follow-up visits occur at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months after treatment ends to check long-term outcomes. The study measures include determining the best dose, observing tumor responses, tracking side effects, and analyzing drug levels over time.

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma