NCT05394103RecruitingPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Qurient Co., Ltd.
- Enrollment
- 130
- Locations
- 9
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Dose escalation (Q901)
Experimental
Intervention: Q901 (Drug)
Q901 Single-Agent Expansion Cohorts
Experimental
Intervention: Q901 (Drug)
Q901 + KEYTRUDA® (pembrolizumab) Cohorts
Experimental
Intervention: Q901 (Drug)
Q901 + KEYTRUDA® (pembrolizumab) Cohorts
Experimental
Intervention: KEYTRUDA® (pembrolizumab) (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 28 days of cycle 1 (each cycle is 28 days)
Secondary Outcomes
- 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))
Investigators
Study Sites (9)
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