Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-08-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qurient Co., Ltd.

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