A Phase II Study Evaluating the Safety, Efficacy, and Intracranial Activity of Tarlatamab in Recurrent/Refractory Gliomas With IDH Mutation (TARGID)
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.
• 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 indicated surgical resection/debulking, or willing to undergo post-treatment tumor biopsy.
• Patients in Cohort 2 must be willing to provide tumor samples should they require surgical resection/debulking or undergo clinically indicated tumor biopsy after enrollment in trial.
• Patients in Cohort 2 must have measurable and progressive disease documented within 28 days of start of study treatment
• Patients must be asymptomatic and meet the following criteria:
• At least 28 days after the most recent CNS treatment, clinically stable.
• At least 14 days on stable doses of corticosteroids and/or anti-seizure medications.