Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05438420

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Esophageal Cancer Cervical Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Hepatocellular Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHA Bundang Medical Center, Seongnam-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
  • Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 3 months

Exclusion criteria

  • A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
  • Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
  • Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
  • Has had an allogeneic tissue/solid organ transplant

Treatment and study plan

Q702

Drug

The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.

Pembrolizumab

Biological

Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle

Other names: KEYTRUDA®

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE

    Time frame: Up to approximately 2 years (Each Cycle is 42 Days)

  2. Tumor response using RECIST version 1.1 throughout study

    Time frame: Up to approximately 2 years (Each Cycle is 42 Days)

Secondary outcomes

  1. Change in the area under curve (AUC) of Q702 and its primary metabolites

    Time frame: Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 30, 2022
Registry last updated
Feb 24, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.