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Completed

NCT Number: NCT04648254

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

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.

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Key information

Conditions

Solid Tumor Advanced Cancer Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q702

Drug

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 outcomes

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

    Time frame: 28 days of cycle 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2020
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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