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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04648254
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 18, 2020
Estimated Primary Completion Date : July 18, 2023
Estimated Study Completion Date : November 18, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702 [ Time Frame: 28 days of cycle 1 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Tumor response using RECIST version 1.1 throughout study [ Time Frame: Baseline up to approximately 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648254


Contacts
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Contact: Qurient Clinical Trial Information +82-31-8060-1610 ext (KST) clinicaltrial_info@qurient.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: See Central Contact         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: See Central Contact         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: See Central Contact         
United States, New Jersey
Atlantic Health System Hospital Recruiting
Morristown, New Jersey, United States, 07960
Contact: See Central Contact         
Sponsors and Collaborators
Qurient Co., Ltd.
More Information
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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT04648254    
Other Study ID Numbers: Q702-ONC-P1-US001
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes