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NCT05394103PHASE1, PHASE2Recruiting

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Qurient Co., Ltd.

Start Date

8/30/2022

Completion Date

8/30/2026

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Q901

DRUG

KEYTRUDA® (pembrolizumab)

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Conditions

Advanced CancerMetastatic Cancer

Locations

Mayo Clinic

Phoenix, Arizona 85054

United States

University of Southern California

Los Angeles, California 90033

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Northwestern University

Chicago, Illinois 60611

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Atlantic Health System Hospital

Morristown, New Jersey 07960

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

National Cancer Center

Goyang-si,

South Korea

CHA University Bundang Medical Center

Seongnam-si,

South Korea

Asan Medical Center

Seoul,

South Korea

Severance Hospital

Seoul,

South Korea