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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Trial Status: active
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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05394103.
