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NCT05394103 | RECRUITING | Advanced Cancer

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Sponsor:

Qurient Co., Ltd.

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

Condition or disease

Advanced Cancer

Metastatic Cancer

Intervention/treatment

Q901

KEYTRUDA® (pembrolizumab)

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-08-30
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Location Details

NCT05394103

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New Jersey

Atlantic Health System Hospital

Morristown, New Jersey, United States, 07960

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

NOT YET RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

Severance Hospital

Seoul, Korea, Republic of,