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
Qurient Co., Ltd.
130 participants
Aug 30, 2022
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria4
- 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
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Interventions
The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter
KEYTRUDA® (pembrolizumab) will be administered Q6W
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT05394103