Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
NCT ID: NCT05438420
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2023-01-12
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
NCT05101070
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
NCT07050459
Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors
NCT05145907
Study of GV20-0251 in Participants With Solid Tumor Malignancies
NCT07070518
First in Human Study of SIM0610 in Solid Tumors
NCT07348211
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose escalation of Q702 in combination with fixed dose of pembrolizumab
Give one week on/one week off at selected dose level
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.
Pembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Give intravenously once every three week at 200 mg
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.
Pembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Pembrolizumab
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Qurient Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Southern California
Los Angeles, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
CHA Bundang Medical Center
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-3475-D35 (KEYNOTE-D35)
Identifier Type: OTHER
Identifier Source: secondary_id
QRNT-008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.