NCT05394103PHASE1, PHASE2Recruiting
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Qurient Co., Ltd.
Start Date
8/30/2022
Completion Date
8/30/2026
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
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit
* Measurable disease per RECIST v 1.1
* ECOG performance status 0,1 or 2
* Life expectancy of at least 3 months
* Age ≥ 18 years
* Signed, written IRB-approved informed consent form
Exclusion Criteria:
* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males)
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Active, poorly controlled autoimmune or inflammatory diseases
Interventions
DRUG
Q901
DRUG
KEYTRUDA® (pembrolizumab)
Conditions
Advanced CancerMetastatic Cancer
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
University of Southern California
Los Angeles, California 90033
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Northwestern University
Chicago, Illinois 60611
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Atlantic Health System Hospital
Morristown, New Jersey 07960
United States
Mary Crowley Cancer Research
Dallas, Texas 75230
United States
National Cancer Center
Goyang-si,
South Korea
CHA University Bundang Medical Center
Seongnam-si,
South Korea
Asan Medical Center
Seoul,
South Korea
Severance Hospital
Seoul,
South Korea