Clinical trial NCT04648254: Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Advanced Cancer
Metastatic Cancer
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
timeFrame: 28 days of cycle 1
Secondary outcomes:
measure: Change in the area under curve (AUC) of Q702
timeFrame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
measure: Change in the maximum plasma concentration (Cmax) of Q702
timeFrame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
measure: Change in the time of maximum plasma concentration (Tmax) of Q702
timeFrame: Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
measure: Tumor response using RECIST version 1.1 throughout study
timeFrame: Baseline up to approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Morristown
country: United States
facility: Atlantic Health System Hospital
state: New Jersey
Study officials:
References:
citation: Jeon Y, Kang H, Yang Y, Park D, Choi B, Kim J, Kim J, Nam K. A Novel Selective Axl/Mer/CSF1R Kinase Inhibitor as a Cancer Immunotherapeutic Agent Targeting Both Immune and Tumor Cells in the Tumor Microenvironment. Cancers (Basel). 2022 Oct 2;14(19):4821. doi: 10.3390/cancers14194821.