Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Cancer, Metastatic Cancer

In brief

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

Key facts

Study ID

NCT05394103

Run by

Qurient Co., Ltd.

People needed

130

Starts

2022-08-30

Expected to finish

2026-08-30

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Atlantic Health System Hospital — Morristown, New Jersey, United States (enrolling)
• Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• National Cancer Center — Goyang-si, South Korea (enrolling)
• CHA University Bundang Medical Center — Seongnam-si, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea
• Severance Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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