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

A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous 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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Gastric Cancer; Esophageal Cancer; Hepatocellular Cancer
• Intervention / Treatment: Drug: Q702; Biological: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qurient Clinical Trial Information; Phone Number: +82-31-8060-1610; Email: clinicaltrial_info@qurient.com

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • CHA Bundang Medical Center
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: See Central Contact
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Asan Medical Center
    • Contact: See Central Contact
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: See Central Contact
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation of Q702 in combination with fixed dose of pembrolizumab; Give one week on/one week off at selected dose level	Drug: Q702; 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.; Biological: Pembrolizumab; Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle; Other Names: KEYTRUDA®
Experimental: Dose expansion of Q702 in combination with fixed dose of pembrolizumab; Give intravenously once every three week at 200 mg	Drug: Q702; 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.; Biological: Pembrolizumab; Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle; Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE	Up to approximately 2 years (Each Cycle is 42 Days)
Tumor response using RECIST version 1.1 throughout study	Up to approximately 2 years (Each Cycle is 42 Days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the area under curve (AUC) of Q702 and its primary metabolites	Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)

Collaborators and Investigators

• Sponsor: Qurient Co., Ltd.
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: QRNT-008; MK-3475-D35 (KEYNOTE-D35) (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No