Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Sponsor: Qurient Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05394103

Patient View

This trial evaluates the safety and antitumor activity of Q901, alone and with pembrolizumab, in advanced solid tumors. Eligible participants have specific cancers, measurable disease, ECOG 0-2, and a life expectancy of ≥3 months. Q901 is given via IV infusion weekly for 4 weeks, then biweekly; pembrolizumab is administered every 6 weeks. Participants must be 18+ and provide informed consent.

Patient Parameters

Program 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

Eligibility 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

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