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

Sponsor

Qurient Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04648254

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

19.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Advanced Cancer Metastatic Cancer	Drug: Q702	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Jul 18, 2023

Anticipated Study Completion Date :

Nov 18, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Northwestern University	Chicago	Illinois	United States	60611
4	Atlantic Health System Hospital	Morristown	New Jersey	United States	07960

Sponsors and Collaborators

Qurient Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qurient Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04648254

Other Study ID Numbers:

Q702-ONC-P1-US001

First Posted:

Dec 1, 2020

Last Update Posted:

Jul 30, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Jul 30, 2021