Study of How Safe and Effective Tarlatamab is in Brain Cancers (NCT06776250) | Clinical Trial Compass
RecruitingPhase 2
Study of How Safe and Effective Tarlatamab is in Brain Cancers
Canada44 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures.
* Must be 18 years of age or older.
* Body weight \> 40 kg.
* Patients must have histologically or cytologically confirmed diffuse astrocytic or oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant.
* Patients could have received up to 2 regimens of systemic therapy after relapse.
* For Cohort 1: Patient must be clinically deemed resectable and a resection is clinically indicated.
* For Cohort 2: Patient must be unresectable or a resection is not clinically indicated at the time of enrollment.
* Patients must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Patients must have a life expectancy ≥ 12 weeks.
* Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to start of therapy and Day 1 prior to start of therapy.
* All participants must agree to use 2 acceptable methods to prevent pregnancy for study required duration.
* Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
* All patients in Cohort 1 and Cohort 2 are required to submit archival tissue. In addition,
* Patients in Cohort 1 must be willing to provide fresh tumor samples at the time of clinically indicate…