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)
In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administer twice daily, PO, 4-week continuous dose.
Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGMaximum Tolerated Dose(MTD)
MTD will be assessed based on dose-limiting toxicity(DLT) assessment
Time frame: From baseline up to disease progression, approximately 4 weeks
Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I.
RP2D will be assessed based on MTD.
Time frame: From baseline up to disease progression, approximately 48 weeks
Disease control rate(DCR)
DCR is defined as the proportion of participants who achieved a confirmed best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD)
Time frame: From baseline up to disease progression, approximately 48 weeks
Progression-free survival(PFS) rate at 6 months
PFS is defined as the time from the start of study treatment to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever is earlier
Time frame: From baseline up to 6 months
Pharmacokinetic(PK) of maximum serum Concentration (Cmax)
Plasma concentrations at each time point and PK parameters Cmax of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 4 weeks post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 4 weeks post-dose
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Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)
Plasma concentrations at each time point and PK parameters AUC last of BEY1107 will be assessed in the PK sampling cohort
Time frame: From baseline up to 4 weeks post-dose