RECRUITING

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-08-30
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05394103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Measurable disease per RECIST v 1.1
  3. * ECOG performance status 0,1 or 2
  4. * Life expectancy of at least 3 months
  5. * Age ≥ 18 years
  6. * Signed, written IRB-approved informed consent form
  1. * 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
  2. * Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males)
  3. * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  4. * Active, poorly controlled autoimmune or inflammatory diseases

Contacts and Locations

Study Contact

Qurient Clinical Trial Information
CONTACT
+82-31-8060-1610
clinicaltrial_info@qurient.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Qurient Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Cancer
  • Metastatic Cancer