NCT06776250

Study of How Safe and Effective Tarlatamab is in Brain Cancers

A Phase II Study Evaluating the Safety, Efficacy, and Intracranial Activity of Tarlatamab in Recurrent/Refractory Gliomas With IDH Mutation (TARGID)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to assess how useful study drug tarlatamab is for the treatment of patients with recurrent/refractory oligodendroglioma or astrocytoma with a mutation in the IDH gene.

Detailed description

There will be 2 cohorts in the study. * Cohort 1, patients whose disease is amendable for resection will be treated with up to 3 cycles of tarlatamab prior to surgical resection. These patients can resume tarlatamab treatment post-operatively until disease progression at the discretion of the investigator. Up to 10 patients may be enrolled to Cohort 1. * Cohort 2, patients with progressive/refractory disease are eligible to receive tarlatamab at Q2W 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity or consent withdrawal. The Simon's 2 stage design will be used. In stage 1, 13 patients will be enrolled. Based on an interim analysis of efficacy, stage 2 will aim to enroll an additional 21 patients for a total of 34 patients.

Conditions

• Astrocytic Tumor
• Oligodendroglial Tumor

Interventions

Type	Name	Description
DRUG	Tarlatamab	Tarlatamab is a BiTE molecule designed to direct T effector cells toward DLL3-expressing cells.

Timeline

• Start date: 2025-08-18
• Primary completion: 2028-03-03
• Completion: 2028-03-03
• First posted: 2025-01-15
• Last updated: 2025-09-19

Locations

1 site across 1 country: Canada