Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05394103

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Led by Qurient Co., Ltd. · Updated on 2025-08-17

130

Participants Needed

11

Research Sites

208 weeks

Total Duration

On this page

Sponsors

Q

Qurient Co., Ltd.

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer
  • Disease measurable by RECIST v 1.1 criteria
  • ECOG performance status of 0, 1, or 2
  • Life expectancy of at least 3 months
  • Signed, written informed consent approved by an IRB
Not Eligible

You will not qualify if you...

  • New York Heart Association Class III or IV cardiac disease
  • Myocardial infarction, severe unstable angina, coronary or peripheral artery bypass graft, or congestive heart failure within the past 6 months
  • Corrected QT interval (QTcF) greater than 470 msec for females and greater than 450 msec for males
  • Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
  • Active, poorly controlled autoimmune or inflammatory diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 11 locations

1

Mayo Clinic

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

3

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

4

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

6

Atlantic Health System Hospital

Morristown, New Jersey, United States, 07960

Actively Recruiting

7

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

Actively Recruiting

8

National Cancer Center

Goyang-si, South Korea

Actively Recruiting

9

CHA University Bundang Medical Center

Seongnam-si, South Korea

Actively Recruiting

10

Asan Medical Center

Seoul, South Korea

Not Yet Recruiting

11

Severance Hospital

Seoul, South Korea

Not Yet Recruiting

Loading map...

Research Team

Q

Qurient Clinical Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here