Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394103
• Other study ID #: QRNT-009
• Secondary ID: MK-3475-E45 (KEY
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 30, 2022
• Est. completion date: August 30, 2026

Study information

• Verified date: March 2024
• Source: Qurient Co., Ltd.
• Contact: Qurient Clinical Trial Information
• Phone: +82-31-8060-1610
• Email: clinicaltrial_info[@]qurient.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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
• KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab) will be administered Q6W

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
United States	Northwestern University	Chicago	Illinois
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Southern California	Los Angeles	California
United States	Atlantic Health System Hospital	Morristown	New Jersey
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Qurient Co., Ltd.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)