This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral capsule, QD
University of Southern California
Los Angeles, California, United States
University of Colorado Denver
Denver, Colorado, United States
Northwestern University
Evanston, Illinois, United States
Dose limiting toxicities (DLTs)
DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
Time frame: 28 days
Treatment-emergent adverse events (TEAEs)
Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
Time frame: 24 months
The pharmacokinetics of STP1002
Plasma concentration of STP1002 following oral administration
Time frame: 24 months
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