Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors

This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts), and to assess the clinical activity of this therapeutic strategy in three parallel, histology-defined cohorts (IDH-mutant glioma, other gliomas, and other CNS tumors). A pre-screening to detect DLL3 expression by IHC on archival tumor sample must be performed before the therapeutic part. Only patients with DLL3 positive tumor on IHC can be enrolled in the therapeutic part. This pre-screening must be optimally performed during the ongoing treatment line i.e. before documented progression to not delay treatment starts at time of progression. Tumor samples (surgery or biopsy specimen) will be sent to a central lab for IHC testing.

NCT Number	NCT07243470
Lead Sponsor	Centre Leon Berard Collaborators: Amgen, National Cancer Institute, France
Conditions	Glioma, CNS Tumor, Adult, CNS Tumor, Childhood
Enrollment	70 participants
Start Date	2025-11-04
Primary Completion	2029-10 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-27