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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
Additional locations may be listed on ClinicalTrials.gov for NCT05394103.
