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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Drug: Q901; Drug: KEYTRUDA® (pembrolizumab)

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qurient Clinical Trial Information; Phone Number: +82-31-8060-1610; Email: clinicaltrial_info@qurient.com

Study Locations

• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • Recruiting
    • National Cancer Center
    • Contact: See Central Contact
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • CHA University Bundang Medical Center
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Asan Medical Center
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Severance Hospital
    • Contact: See Central Contact
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic
      • Contact: See Central Contact
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: See Central Contact
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: See Central Contact
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: See Central Contact
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: See Central Contact
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health System Hospital
      • Contact: See Central Contact
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Mary Crowley Cancer Research
      • Contact: See Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation (Q901)	Drug: 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
Experimental: Q901 Single-Agent Expansion Cohorts	Drug: 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
Experimental: Q901 + KEYTRUDA® (pembrolizumab) Cohorts	Drug: 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; Drug: KEYTRUDA® (pembrolizumab); KEYTRUDA® (pembrolizumab) will be administered Q6W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Qurient Co., Ltd.
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pembrolizumab
• Other Study ID Numbers: QRNT-009; MK-3475-E45 (KEYNOTE-E45) (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No