🏛️ Verified NIH Record • Updated 2025-08-13

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors (NCT05394103)

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

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Qurient Co., Ltd.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (5 items).

Location: Mayo Clinic — Phoenix, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

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

📞 Contact the Study Coordinator

Phone: +82-31-8060-1610

Email: clinicaltrial_info@qurient.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Advanced Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗