Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter
KEYTRUDA® (pembrolizumab) will be administered Q6W
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 28 days of cycle 1 (each cycle is 28 days)
Change in the area under curve (AUC) of Q901
Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the maximum plasma concentration (Cmax) of Q901
Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the time of maximum plasma concentration (Tmax) of Q901
Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Tumor response using RECIST version 1.1 throughout study
Time frame: Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)
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Mayo Clinic
Jacksonville, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGAtlantic Health System Hospital
Morristown, New Jersey, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
RECRUITINGNational Cancer Center
Goyang-si, South Korea
RECRUITINGCHA University Bundang Medical Center
Seongnam-si, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
NOT_YET_RECRUITING...and 1 more locations