Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Sponsor: Qurient Co., Ltd.
Sponsor score: 0
ClinicalTrials ID:NCT05394103
This trial evaluates the safety and antitumor activity of Q901, alone and with pembrolizumab, in advanced solid tumors. Eligible participants have specific cancers, measurable disease, ECOG 0-2, and a life expectancy of ≥3 months. Q901 is given via IV infusion weekly for 4 weeks, then biweekly; pembrolizumab is administered every 6 weeks. Participants must be 18+ and provide informed consent.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 85054 | Phoenix | Arizona |
| University of Southern California | 90033 | Los Angeles | California |
| Mayo Clinic | 32224 | Jacksonville | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Atlantic Health System Hospital | 07960 | Morristown | New Jersey |
| Mary Crowley Cancer Research | 75230 | Dallas | Texas |
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