Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Metastatic Cancer; Advanced Cancer
• Interventions: Drug: Q901; Drug: KEYTRUDA® (pembrolizumab)

• Registration Number: NCT05394103
• Lead Sponsor: Qurient Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-27
• Study Start: 2022-08-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Q901 + KEYTRUDA® (pembrolizumab) Cohorts	KEYTRUDA® (pembrolizumab)	-
Dose escalation (Q901)	Q901	-
Q901 + KEYTRUDA® (pembrolizumab) Cohorts	Q901	-
Q901 Single-Agent Expansion Cohorts	Q901	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	28 days of cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Name	Time	Method
Change in the area under curve (AUC) of Q901	Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Change in the maximum plasma concentration (Cmax) of Q901	Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
Tumor response using RECIST version 1.1 throughout study	Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)
Change in the time of maximum plasma concentration (Tmax) of Q901	Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)

Trial Locations

Locations (7)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Atlantic Health System Hospital; 🇺🇸 Morristown, New Jersey, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States