NCT04648254CompletedPhase 1
A Phase 1, Multicenter, Open-label, Dose- Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 With a Cohort Expansion at the RP2D in Patients With Advanced Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Qurient Co., Ltd.
- Enrollment
- 51
- Locations
- 4
- Primary Endpoint
- Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
Study Overview
Brief Summary
This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- 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
- •Patients with histologically or cytologically confirmed advanced or metastatic solid tumors, that have progressed following standard of care therapy or for which there is no standard therapy which confers clinical benefit
- •Measurable disease per RECIST v 1.1
- •ECOG performance status 0 or 1
- •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 (Q702)
Experimental
Participants will receive escalating doses of Q702
Intervention: Q702 (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
Time Frame: 28 days of cycle 1
Secondary Outcomes
- Tumor response using RECIST version 1.1 throughout study(Baseline up to approximately 2 years)
- Change in the maximum plasma concentration (Cmax) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
- Change in the time of maximum plasma concentration (Tmax) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
- Change in the area under curve (AUC) of Q702(Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22)
Investigators
Study Sites (4)
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