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

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ClinicalTrials.gov Identifier: NCT04648254
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 19, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE November 18, 2020
Estimated Primary Completion Date July 18, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702 [ Time Frame: 28 days of cycle 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • Tumor response using RECIST version 1.1 throughout study [ Time Frame: Baseline up to approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Dose escalation (Q702)
Participants will receive escalating doses of Q702
Intervention: Drug: Q702
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 18, 2023
Estimated Primary Completion Date July 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qurient Clinical Trial Information +82-31-8060-1610 ext (KST) clinicaltrial_info@qurient.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04648254
Other Study ID Numbers  ICMJE Q702-ONC-P1-US001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qurient Co., Ltd.
Study Sponsor  ICMJE Qurient Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qurient Co., Ltd.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP