This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
The study drug Q702 will be administered once daily by mouth on Days 1 through 7 and Days 15 through 21 of every treatment cycle.
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Atlantic Health System Hospital
Morristown, New Jersey, United States
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
Time frame: 28 days of cycle 1
Change in the area under curve (AUC) of Q702
Time frame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Change in the maximum plasma concentration (Cmax) of Q702
Time frame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Change in the time of maximum plasma concentration (Tmax) of Q702
Time frame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Tumor response using RECIST version 1.1 throughout study
Time frame: Baseline up to approximately 2 years
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