New treatment for advanced solid tumors using Q901 and pembrolizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and potential effectiveness of Q901, a highly selective CDK7 inhibitor, in patients with advanced or metastatic solid tumors. It is a multicenter, open-label study that includes a dose-escalation phase followed by a dose expansion at the recommended phase 2 dose (RP2D). Participants will receive Q901 either as a monotherapy or in combination with pembrolizumab, a known immunotherapy agent. The study aims to assess the drug's pharmacokinetics, pharmacodynamics, and overall tolerability.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Atlantic Health System Hospital
  Morristown, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Qurient Clinical Trial Information
• Email: clinicaltrial_info@qurient.com
• Phone: +82-31-8060-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.