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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438420
• Other study ID #: QRNT-008
• Secondary ID: MK-3475-D35 (KEY
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 12, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Qurient Co., Ltd.
• Contact: Qurient Clinical Trial Information
• Phone: +82-31-8060-1610
• Email: clinicaltrial_info[@]qurient.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cervical Cancer
• Esophageal Cancer
• Gastric Cancer
• Hepatocellular Cancer
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
United States	University of Southern California	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Qurient Co., Ltd.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE		Up to approximately 2 years (Each Cycle is 42 Days)
Primary	Tumor response using RECIST version 1.1 throughout study		Up to approximately 2 years (Each Cycle is 42 Days)
Secondary	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)