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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648254
• Other study ID #: Q702-ONC-P1-US001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 18, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: December 2023
• Source: Qurient Co., Ltd.
• Contact: Qurient Clinical Trial Information
• Phone: +82-31-8060-1610
• Email: clinicaltrial_info[@]qurient.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Atlantic Health System Hospital	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Qurient Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702		28 days of cycle 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Tumor response using RECIST version 1.1 throughout study		Baseline up to approximately 2 years