Ireland
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Recruiting Phase 1/2

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

NCT05394103 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2022-08-30
Last updated
2025-08-17

Condition(s) studied

Advanced CancerMetastatic Cancer

Investigational drug(s) / intervention(s)

Q901KEYTRUDA® (pembrolizumab) →

Q901: 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): KEYTRUDA® (pembrolizumab) will be administered Q6W

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — 28 days of cycle 1 (each cycle is 28 days)

Trial sites (11)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Recruiting
University of Southern California Los Angeles California Recruiting
Mayo Clinic Jacksonville Florida Recruiting
Northwestern University Chicago Illinois Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Atlantic Health System Hospital Morristown New Jersey Recruiting
Mary Crowley Cancer Research Dallas Texas Recruiting
National Cancer Center Goyang-si South Korea Recruiting
CHA University Bundang Medical Center Seongnam-si South Korea Recruiting
Asan Medical Center Seoul South Korea Not Yet Recruiting
Severance Hospital Seoul South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05394103 on ClinicalTrials.gov ↗ ← All trials in the USA