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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- Q901 (drug)
- KEYTRUDA® (pembrolizumab) (drug)
Sponsor: Qurient Co., Ltd. · Participants: 130 · Started: Aug 30, 2022
Contact the study team
- Qurient Clinical Trial Information · Phone: +82-31-8060-1610
Official record on ClinicalTrials.gov — NCT05394103
Locations in the U.S.
| Arizona | Mayo Clinic, Phoenix |
| California | University of Southern California, Los Angeles |
| Florida | Mayo Clinic, Jacksonville |
| Illinois | Northwestern University, Chicago |
| Minnesota | Mayo Clinic, Rochester |
| New Jersey | Atlantic Health System Hospital, Morristown |
| Texas | Mary Crowley Cancer Research, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.