This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
QBS10072S targets cancers with high LAT1 expression.
St George Private Hospital
Kogarah, New South Wales, Australia
Sydney Southwest Private Hospital
Liverpool, New South Wales, Australia
Determination of maximum tolerated dose (MTD)
MTD will be determined by presence of AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Time frame: 28 days
Safety and tolerability assessed by adverse events and serious adverse events
Safety and tolerability will be determined by adverse events as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Time frame: 28 days
Peak Plasma Concentration (Cmax)
Determine the maximum plasma concentration of QBS10072S.
Time frame: 28 days
Area under the plasma concentration versus time curve (AUC) of QBS10072S
Determine the plasma concentration of QBS10072S over time.
Time frame: 28 days
Half-life of QBS10072S in plasma (t1/2)
Determine the half life of QBS10072S in plasma; the half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value.
Time frame: 28 days
Time to maximum concentration of QBS10072S in plasma (Tmax)
Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.
Time frame: 28 days
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