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

NCT04648254 | Completed Phase 1 FDA Drug

• 1 other identifier: Q702-ONC-P1-US001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

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.

Conditions

Solid Tumor; Advanced Cancer; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702

  28 days of cycle 1

Secondary Outcomes (4)

• 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

Study Arms (1)

Dose escalation (Q702)

EXPERIMENTAL

Participants will receive escalating doses of Q702

Drug: Q702

Interventions

Q702 DRUG

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.

Dose escalation (Q702)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qurient Co., Ltd.: lead

Study Sites (4)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Atlantic Health System Hospital

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

• 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.

  PMID: 36230744 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 1, 2020
• Study Start: November 18, 2020
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (4)