Status:
RECRUITING
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Lead Sponsor:
Qurient Co., Ltd.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 monother...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05394103
Start Date
August 30 2022
End Date
August 30 2026
Last Update
August 17 2025
Active Locations (11)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
University of Southern California
Los Angeles, California, United States, 90033
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Northwestern University
Chicago, Illinois, United States, 60611