A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose
Summary
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
Arms & interventions
- DrugQ901
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
- DrugKEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab) will be administered Q6W
Outcome measures
Primary
Number 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)
Secondary
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)
Eligibility criteria
Study locations (7)
Mayo Clinic
Phoenix, Arizona, 85054
University of Southern California
Los Angeles, California, 90033
Mayo Clinic
Jacksonville, Florida, 32224
Northwestern University
Chicago, Illinois, 60611
Mayo Clinic
Rochester, Minnesota, 55905
Atlantic Health System Hospital
Morristown, New Jersey, 07960
Mary Crowley Cancer Research
Dallas, Texas, 75230