Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
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
2 other identifiers
interventional
130
2 countries
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
ExpectedAugust 17, 2025
August 1, 2025
3.3 years
May 19, 2022
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
28 days of cycle 1 (each cycle is 28 days)
Secondary Outcomes (4)
Change in the area under curve (AUC) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the maximum plasma concentration (Cmax) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the time of maximum plasma concentration (Tmax) of Q901
Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Tumor response using RECIST version 1.1 throughout study
Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)
Study Arms (3)
Dose escalation (Q901)
EXPERIMENTALQ901 Single-Agent Expansion Cohorts
EXPERIMENTALQ901 + KEYTRUDA® (pembrolizumab) Cohorts
EXPERIMENTALInterventions
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) will be administered Q6W
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qurient Co., Ltd.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (11)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 27, 2022
Study Start
August 30, 2022
Primary Completion
December 30, 2025
Study Completion (Estimated)
August 30, 2026
Last Updated
August 17, 2025
Record last verified: 2025-08