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Monoclonal Antibodies
GT103 + Pembrolizumab for Lung Cancer
Phase 2
Waitlist Available
Led By Jeffrey Clarke, MD
Research Sponsored by Jeffrey Clarke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial assesses safety & effectiveness of an experimental drug combo to treat advanced lung cancer in adults. Safety lead-in of 10-20 patients, then 50-60 total.
Who is the study for?
Adults over 18 with Stage III-IV recurrent or metastatic NSCLC, who have relapsed or are refractory to immunotherapy and possibly chemotherapy. They must have adequate organ function, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have other conditions that might interfere with the trial.Check my eligibility
What is being tested?
The trial is testing GT103 in combination with Pembrolizumab for safety and effectiveness in treating NSCLC. It includes an initial phase to determine the safest dose followed by treatment of up to 60 patients at this dose level.See study design
What are the potential side effects?
While specific side effects for GT103 aren't listed, Pembrolizumab can cause immune system reactions affecting organs, fatigue, infusion-related reactions like fever or chills, skin rash, digestive issues such as diarrhea or liver inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the Frequency and Severity of Adverse Events
Objective Response Rate (ORR)
Secondary outcome measures
Characterize PK Profile: Area Under the Plasma Concentration vs Time Curve (AUC)
Characterize PK Profile: Peak Plasma Concentration (Cmax)
Characterize PK Profile: T1/2 of GT103 in combination with Pembrolizumab
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment2 Interventions
Pembrolizumab will be given intravenously on Day 1 of the 21 day cycle (For all cycles).
GT103 dose will be determined by the safety lead in prior to the study. Dosing calculations should be based on actual body weight where applicable. It will be taken intravenously on Day 1 of the 21 day cycle (For all cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Jeffrey ClarkeLead Sponsor
3 Previous Clinical Trials
92 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,521 Total Patients Enrolled
Grid TherapeuticsUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with stage III or IV recurrent or metastatic non-small cell lung cancer.You cannot tolerate pembrolizumab or other drugs that help the immune system fight cancer.You are currently taking certain medications that are not allowed for this study, such as strong corticosteroids or other drugs that weaken the immune system.You have previously received immunotherapy and it did not work. You may have had other types of treatment before, but no more than two.You have received a transplant from another person, such as a stem cell or organ transplant.You need to be in good physical condition, with minimal limitations in your daily activities.You have an autoimmune condition that needs strong medication to control it, other than a low dose of prednisone or a similar drug.You have received any kind of cancer treatment within the 14 days before starting the study.You have cancer that has spread to your brain and is causing symptoms. If you have been treated for these brain metastases and they are under control, or if they are not causing symptoms, you may still be eligible. If you have brain metastases that have not been treated and are not causing symptoms that require medication, you may also be eligible.You have a history of lung disease that required steroids, or you currently have lung disease.You have specific genetic mutations and have already tried at least one oral targeted therapy and one chemotherapy treatment. You can't have had more than two previous lines of treatment.You have a serious ongoing infection that needs strong medication, but it's okay if you're taking antibiotics to prevent infections.Your disease must be able to be measured using specific criteria. If you had radiation treatment before, any tumor growth in the treated area will also be measured.You have HIV, AIDS, active hepatitis B, or other serious chronic infections that need ongoing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group
Awards:
This trial has 1 awards, including:- 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 this investigation accepting new participants?
"According to the current information on clinicaltrials.gov, this medical experiment is actively seeking participants with postings first made on February 17th 2023 and most recently updated February 23rd."
Answered by AI
Has the FDA approved Experimental Group's products for use?
"Our team at Power approximated the safety of Experimental Group with a score of 2, as this is only in Phase 2. Thus far, there has been data to support its safety but not its efficacy."
Answered by AI
Is there a finite limit to the number of volunteers taking part in this clinical experiment?
"Affirmative. The clinical trial, posted on February 17th 2023 and most recently revised on the 23rd of the same month, is actively seeking participants according to data hosted by clinicaltrials.gov. In total, 50 individuals are being recruited from 1 medical centre."
Answered by AI
What outcomes is this research attempting to accomplish?
"This 3-year clinical trial is designed to measure the incidence and magnitude of adverse events. Pharmacokinetic analysis will be used to assess three secondary outcomes: 1) The time it takes for GT103 to reach its peak concentration when administered with Pembrolizumab (Tmax); 2) The maximum serum concentration of GT103 after administration in combination with Pembrolizumab (Cmax); and, 3) Area under the plasma concentration vs time curve (AUC)."
Answered by AI
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