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PD-1 Inhibitor
Q702 + Pembrolizumab for Advanced Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Qurient Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 and day 22 (each cycle is 42 days)
Awards & highlights
Study Summary
This trialis testing a new combination of drugs to treat advanced cancers of the esophagus, stomach, liver, and cervix.
Who is the study for?
This trial is for adults with advanced esophageal, gastric/GEJ, hepatocellular, or cervical cancers that worsened after anti-PD1/PD-L1 therapy. Participants must be able to consent, have measurable disease per RECIST v1.1., an ECOG status of 0 or 1, and a life expectancy over 3 months. Pregnant or breastfeeding women and those on certain drugs are excluded.Check my eligibility
What is being tested?
The study tests the safety and early effectiveness of Q702 combined with pembrolizumab in selected cancer patients. It's an open-label phase 1B/2 trial where all participants receive the experimental drug combination to see how well it works.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy like fatigue, skin reactions, inflammation-related symptoms across various organs (e.g., colitis), as well as issues specific to tyrosine kinase inhibitors such as hypertension and diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured using standard imaging tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer has worsened despite treatment with specific immune therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 1 and day 22 (each cycle is 42 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 and day 22 (each cycle is 42 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Tumor response using RECIST version 1.1 throughout study
Secondary outcome measures
Change in the area under curve (AUC) of Q702 and its primary metabolites
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose expansion of Q702 in combination with fixed dose of pembrolizumabExperimental Treatment2 Interventions
Give intravenously once every three week at 200 mg
Group II: Dose escalation of Q702 in combination with fixed dose of pembrolizumabExperimental Treatment2 Interventions
Give one week on/one week off at selected dose level
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Qurient Co., Ltd.Lead Sponsor
8 Previous Clinical Trials
687 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,937 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong medication that affects enzyme activity in my body.My cancer can be measured using standard imaging tests.I am not taking any medications that interact with the study drug.I am fully active or restricted in physically strenuous activity but can do light work.I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.I am not pregnant or breastfeeding.You are expected to live for at least 3 more months.I have received a transplant from another person.My cancer has worsened despite treatment with specific immune therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation of Q702 in combination with fixed dose of pembrolizumab
- Group 2: Dose expansion of Q702 in combination with fixed dose of pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for individuals to partake in this research?
"According to information found on clinicaltrials.gov, recruitment for this particular trial has ceased. It was initially posted in December of 2023 and modified one month later; however, there are currently 1441 other trials with active participant enrollment."
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