Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

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

Conditions

Advanced Cancer, Metastatic Cancer

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Morristown

Atlantic Health System Hospital, Morristown, New Jersey, United States, 07960

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Qurient Co., Ltd.,

Study Record Dates

2026-08-30