Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
NCT ID: NCT05394103
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2022-08-30
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation (Q901)
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
Q901 Single-Agent Expansion Cohorts
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
Q901 + KEYTRUDA® (pembrolizumab) Cohorts
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Qurient Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Atlantic Health System Hospital
Morristown, New Jersey, United States
Mary Crowley Cancer Research
Dallas, Texas, 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
Countries
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Central Contacts
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Facility Contacts
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See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
Other Identifiers
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MK-3475-E45 (KEYNOTE-E45)
Identifier Type: OTHER
Identifier Source: secondary_id
QRNT-009
Identifier Type: -
Identifier Source: org_study_id
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