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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCentre Leon Berard

About this trial

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.

Eligibility criteria

Qualifiers

Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;

Lansky PS for patients between 12 and 15y: ≥ 70%;

PS ECOG for adult patients: 0 or 1.

Peripheral absolute neutrophil count (ANC) ≥1.5 G/L (without growth factor support within 7 days)

Disqualifiers

chimeric or humanized antibodies or fusion proteins,

biopharmaceuticals produced in Chinese hamster ovary cells,

or any component of the tarlatamab formulation.

Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or

Trial design

Treatments tested in this trial

  • Tarlatamab
  • Temozolomide (TMZ)

Treatment groups

70 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Centre Leon Berard

Lead sponsor

Amgen

Collaborator

National Cancer Institute, France

Collaborator