Advanced Cancer, Metastatic Cancer
Conditions
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
Interventions
DRUGQ901
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) will be administered Q6W
Sponsors
Merck Sharp & Dohme LLC
Qurient Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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) |
| 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) |
| 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) |
Countries
South Korea, United States
Contacts
Primary ContactQurient Clinical Trial Information
Outcome results
None listed