Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor

Study Overview
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Brief Summary
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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.

Official Title
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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
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Solid Tumor, Advanced Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: Q702


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation (Q702)<br>Participants will receive escalating doses of Q702 | Drug: Q702<br>* The study drug Q702 will be administered once daily by mouth on Days 1 through 7 and Days 15 through 21 of every treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702 |  | 28 days of cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Tumor response using RECIST version 1.1 throughout study |  | Baseline up to approximately 2 years |