Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

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

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

Conditions3

Locations7 sites

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