NCT05394103

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Qurient Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 as a monotherapy and in combination with pembrolizumab

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Q901	The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter
DRUG	KEYTRUDA® (pembrolizumab)	KEYTRUDA® (pembrolizumab) will be administered Q6W

Timeline

• Start date: 2022-08-30
• Primary completion: 2025-12-30
• Completion: 2026-08-30
• First posted: 2022-05-27
• Last updated: 2025-08-17

Locations

11 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study