Study of How Safe and Effective Tarlatamab is in Brain Cancers

Sponsor
University Health Network, Toronto
Study ID
NCT06776250
Phase
PHASE2
Status
Recruiting
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Conditions

  • Astrocytic Tumor
  • Oligodendroglial Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Tarlatamab is a BiTE molecule designed to direct T effector cells toward DLL3-expressing cells.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Sep 2025
Primary completion
Mar 3, 2028
Completion
Mar 3, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: Cohort 2
    Patients with progressive/refractory disease are eligible to receive tarlatamab at every 2 weeks 10 mg dosing in 28 day cycles until documented disease progression, intolerable toxicity or consent withdrawal. Up to 34 patients may be enrolled to Cohort 2.

Primary Outcome Measure

Percent change in CD8+ T cell infiltrate [ Time Frame: 3 years ]

Central Contacts