Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07243470 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: TARLATEM
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites revised (12)v4
  2. Study sites: 11 to 12v3
  3. Site details revised at 2 of 11 sitesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Centre Leon Berard
70 trials monitored
See 2 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
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.
Trial Details
NCT Number NCT07243470
Lead Sponsor Centre Leon Berard
Collaborators: Amgen, National Cancer Institute, France
Conditions
(from sponsor)		 Glioma, CNS Tumor, Adult, CNS Tumor, Childhood
Related terms Central Nervous System Neoplasms, Glioma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov