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NCT05438420 | RECRUITING | Esophageal Cancer

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

Qurient Co., Ltd.

Brief Summary:

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.

Condition or disease

Esophageal Cancer

Gastric Cancer

Hepatocellular Cancer

Cervical Cancer

Intervention/treatment

Q702

Pembrolizumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
Actual Study Start Date : 2023-01-12
Estimated Primary Completion Date : 2025-10-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

Location Details

NCT05438420

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

Korea, Republic of,

CHA BAnding Medical Center

Seongnam-shi, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Severance Hospital

Seoul, Korea, Republic of,