drugset / Trial / NCT07243470
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
Phase 1/2
Recruiting
70 enrolled
Centre Leon Berard
Amgen · collabNational Cancer Institute, France · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-11-04
- Primary completion
- 2029-10
- Completion
- 2030-10
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tarlatamab | Protein / enzyme biologic | 10 mg | Intravenous |
| Subject | Temozolomide | Small molecule | 50 mg/m2 | — |