LSTA1 for subjects with newly diagnosed Glioblastoma Multiforme when added to standard of care (temozolomide) versus temozolomide

Prior treatment

• Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor
• Patients who received prior Gliadel wafers
• Patients with concurrent stereotactic radiosurgery or brachytherapy
• Progression of GBM during or after the standard-of-care radiotherapy and TMZ 6-week regimen.

Other illness

• Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
• Patients with extracranial metastatic disease
• Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1 by MRI. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment

Other

• Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
• Patients with leptomeningeal dissemination
• Participation in another interventional clinical study within the last 1 year

• Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent
• Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention)
• Adequate contraception
• Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification
• Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks
• Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks)
• Subjects must be able to undergo serial MRIs (computerized tomography may not be a substitute for magnetic resonance imaging [MRI]).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
• Life expectancy ≥ 3 months, as determined by the investigator
• Patient may have- or continue to receive corticosteroids, by s/he must be on a stable or decreasing dose for at least 14 days prior to randomization
• Subjects must have adequate organ and marrow function