Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Last updated: March 8, 2024
Sponsor: Qurient Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Metastatic Cancer

Treatment

Q901

Pembrolizumab

KEYTRUDA® (pembrolizumab)

Clinical Study ID

NCT05394103
QRNT-009
MK-3475-E45 (KEYNOTE-E45)
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants with histologically or cytologically confirmed advanced or metastaticovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, orpancreatic cancer, who have progressed following standard-of-care therapy or for whomthere 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

Exclusion Criteria:

  • New York Heart Association Class III or IV cardiac disease, or myocardial infarction,severe unstable angina, coronary/peripheral artery bypass graft, congestive heartfailure within the past 6 months
  • Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470msec (females) and >450 msec (males)
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemictherapy
  • Active, poorly controlled autoimmune or inflammatory diseases

Study Design

Total Participants: 130
Treatment Group(s): 3
Primary Treatment: Q901
Phase: 1/2
Study Start date:
August 30, 2022
Estimated Completion Date:
August 30, 2026

Connect with a study center

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Atlantic Health System Hospital

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

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