A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Trial Parameters
Brief Summary
This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Eligibility Criteria
Inclusion Criteria: 1. Adult males and females aged over 19 years or older at the time of Informed Consent. 2. Diagnosed with GBM according to the World Health Organization(WHO) criteria. 3. Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology. 4. Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria. 5. Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1. 6. For Subjects using corticosteroids, those who do not need escalation within at least 2 weeks prior to administration of Investigational Product(IP) and on a stable dose. 7. Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile. 8 Non-vasectomized men who consent to use an acceptable co