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Record History
All 1 version: 1 with changes below.
Study First Submitted
Endpoints
Primary
Number of Participants Completing the DLT Evaluation Period and Undergoing Planned Surgery Without a DLT
Timeframe: From first neoadjuvant tarlatamab dose through the postoperative safety assessment 7 days after surgery; Cycle 1 is 4 weeks, with dosing on Days 1, 8, and 15 and surgery approximately 2 weeks after Day 15.
Number of Participants With Treatment-Emergent Adverse Events
Timeframe: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Treatment-Related Adverse Events
Timeframe: From first study intervention through 60 days after cessation of study intervention.
Incidence of all treatment-emergent adverse events and treatment-related adverse events.
Timeframe: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Cytokine Release Syndrome by Maximum ASTCT Grade
Timeframe: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With ICANS by Maximum ASTCT Grade
Timeframe: From first study intervention through 60 days after cessation of study intervention.
Secondary (6)
Response rate according to RANO and iRANO criteria.
Progression-free survival (PFS)
Overall survival (OS)
EORTC QLQ-C30 questionnaires.
EORTC QLQ-BN20 questionnaires
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Incidence, severity (graded per CTCAE v5.0 and ASTCT criteria for CRS and ICANS), and type of treatment-emergent adverse events occurring during the adjuvant treatment period.
Arms and interventions
Recurrent high-grade glioma with DDL-3 positive tumor expression, as assessed by IHC.Experimental
Participants with surgically resectable recurrent DLL3-positive high-grade glioma will receive neoadjuvant tarlatamab prior to planned surgery, followed by adjuvant tarlatamab after surgery. In the neoadjuvant phase, tarlatamab will be administered intravenously using a step-up regimen of 1 mg on Cycle 1 Day 1, followed by 10 mg on Days 8 and 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Approximately 3 weeks after surgery, tarlatamab will be restarted with step-up dosing of 1 mg on Day 1, followed by 10 mg on Days 8 and 15, then continued at 10 mg intravenously every 2 weeks for up to 6 cycles, with each cycle defined as 4 weeks.
Biologicals: Tarlatamab
Sites
1 site in 1 country
Hospital Universitari Vall D HebronBarcelona, Catalonia, Spain
