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

Phase 1

Active, not recruiting

• Conditions: Solid Tumor; Advanced Cancer; Metastatic Cancer
• Interventions: Drug: Q702

• Registration Number: NCT04648254
• Lead Sponsor: Qurient Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation (Q702)	Q702	Participants will receive escalating doses of Q702

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702	28 days of cycle 1

Secondary Outcome Measures

Name	Time	Method
Tumor response using RECIST version 1.1 throughout study	Baseline up to approximately 2 years
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
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

Trial Locations

Locations (4)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Atlantic Health System Hospital; 🇺🇸 Morristown, New Jersey, United States