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

Primary Purpose

Solid Tumor, Advanced Cancer, Metastatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Q702
Sponsored by
Qurient Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Northwestern UniversityRecruiting
  • Atlantic Health System HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose escalation (Q702)

Arm Description

Participants will receive escalating doses of Q702

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the area under curve (AUC) of Q702
Change in the maximum plasma concentration (Cmax) of Q702
Change in the time of maximum plasma concentration (Tmax) of Q702
Tumor response using RECIST version 1.1 throughout study

Full Information

First Posted
November 19, 2020
Last Updated
September 1, 2022
Sponsor
Qurient Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04648254
Brief Title
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
July 18, 2023 (Anticipated)
Study Completion Date
November 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qurient Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Advanced Cancer, Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation (Q702)
Arm Type
Experimental
Arm Description
Participants will receive escalating doses of Q702
Intervention Type
Drug
Intervention Name(s)
Q702
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702
Time Frame
28 days of cycle 1
Secondary Outcome Measure Information:
Title
Change in the area under curve (AUC) of Q702
Time Frame
Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Title
Change in the maximum plasma concentration (Cmax) of Q702
Time Frame
Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Title
Change in the time of maximum plasma concentration (Tmax) of Q702
Time Frame
Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Title
Tumor response using RECIST version 1.1 throughout study
Time Frame
Baseline up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qurient Clinical Trial Information
Phone
+82-31-8060-1610
Ext
(KST)
Email
clinicaltrial_info@qurient.com
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact
Facility Name
Atlantic Health System Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Central Contact

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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