A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

Prior treatment

• Subjects who have not recovered from the toxicity of the prior anticancer therapy.
• Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
• Subjects with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
• Subjects who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
• Subjects who had been administered other IP within 4 weeks prior to screening.

Other illness

• Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
• Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
• Subjects with a history of other malignancy except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ, papillary thyroid cancer or early gastric cancer.
• Subjects with hypersensitivity to dacarbazine (DTIC).
• Subjects who have the cardiovascular disease as of screening.
• Active hepatitis B, C or HIV positive.
• Patients with acute or severe infection.

Other

• Subjects with a genetic problem(eg. Galactose intolerance).
• Patients with inadequate bone marrow, kidney and liver function.
• Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
• Subjects with life expectancy of less than 12 weeks by the investigator.
• Subjects determined by the investigator to be ineligible for participation in this trial.

• Adult males and females aged over 19 years or older at the time of Informed Consent.
• Diagnosed with GBM according to the World Health Organization(WHO) criteria.
• Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
• Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
• Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
• 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.
• 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 contraception by one-self and the partner until 3 months after the end of IP administration.
  • 9\. Subjects who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.