Clinical trial NCT05394103: Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Metastatic Cancer
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-05-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 28 days of cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Change in the area under curve (AUC) of Q901
timeFrame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
measure: Change in the maximum plasma concentration (Cmax) of Q901
timeFrame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
measure: Change in the time of maximum plasma concentration (Tmax) of Q901
timeFrame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)
measure: Tumor response using RECIST version 1.1 throughout study
timeFrame: Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health System Hospital
state: New Jersey
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: