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

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

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 Overview

• Status: Completed
• Conditions: Solid Tumor; Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Drug: Q702

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation (Q702); Participants will receive escalating doses of Q702	Drug: Q702; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Qurient Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): December 23, 2025
• Study Completion (Actual): December 23, 2025

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: Q702-ONC-P1-US001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No