Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQurient Co., Ltd.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Q901
- KEYTRUDA® (pembrolizumab)
Treatment groups
130 Participants
are divided into 3 treatment groupsSponsors and collaborators
Qurient Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov