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 pa

Trial Details

NCT ID
NCT07243470
Phase
PHASE1 / PHASE2
Sponsor
Centre Leon Berard
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Tarlatamab
  • Temozolomide (TMZ)
Locations (sample)
  • Angers, France|47.47156,-0.55202
  • Angers, France|47.47156,-0.55202
  • Bordeaux, France|44.84124,-0.58046
  • Bordeaux, France|44.84124,-0.58046
  • Bron, France|45.73865,4.91303

Key Eligibility Criteria

  • I1. Patients aged ≥ 12 years old at time of inform consent signature.
  • I2. Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or othe…
  • I3. Tumors expressing DLL3 based on IHC staining performed on archival tumor sample i.e. at least 1+ on IHC \[patient with no tumor expression of D…
  • Note- This pre-screening by IHC should be optimally initiated during an ongoing line of treatment i.e. before documented progression. The ICF1 must…

For full eligibility, visit ClinicalTrials.gov.

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