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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be more than or equal to (>=)18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, GSK3745417, for treating cancer. The trial will have two parts, each testing different ways of administering the drug.
Who is the study for?
Adults with advanced solid tumors that have worsened or not responded to existing treatments can join this trial. They must be at least 18, have a confirmed diagnosis, measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children need to use effective contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study is testing GSK3745417 alone (Part 1A) or combined with dostarlimab (Part 2A) in patients with stubborn solid tumors. It's in the first phase where they're figuring out safe doses and checking how well it works by gradually increasing the dose.See study design
What are the potential side effects?
Possible side effects are not detailed but may include typical reactions to cancer therapies such as immune-related issues due to dostarlimab (an immunotherapy drug), infusion reactions, fatigue, digestive problems, skin changes, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I can provide a new tissue sample for testing.
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My cancer is confirmed to be advanced through testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parts 1A and 2A: Number of participants achieving dose-limiting toxicity (DLT)
Parts 1A and 2A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity
Secondary outcome measures
Part 1A: Apparent terminal phase half-life (t1/2) following administration of GSK3745417 alone
Part 1A: Area under the concentration-time curve (AUC) following administration of GSK3745417 alone
Part 1A: GSK3745417 concentrations in plasma following administration of GSK3745417 alone
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation CohortExperimental Treatment2 Interventions
Group II: Part 1A: Participants receiving GSK3745417, Dose-escalation CohortExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,355 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,833 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had vasculitis in the past.I am fully active or can carry out light work.My organs are functioning well.I am able to understand and sign the consent form.I haven't taken any immune checkpoint inhibitors in the last 28 days.I have had symptoms of pericarditis in the last 6 months.I have not received a live vaccine in the last 30 days.My liver condition is stable.I haven't had allergy desensitization therapy in the last 4 weeks.I have had radiation but still have at least one tumor that wasn't treated with it.I have an autoimmune disease treated with strong medication in the last 2 years.I have a history of serious bleeding or blood clotting issues.I have had issues like severe gut inflammation or blockage in the last 6 months.I have fully recovered from any recent surgeries before starting the study treatment.I am either male or female.My advanced cancer has not responded to, or I cannot tolerate, all proven treatments.I can provide a new tissue sample for testing.I have had a bone marrow or organ transplant.I haven't used any cancer drugs or investigational devices in the last 28 days or within 5 half-lives of the drug.I am not pregnant or breastfeeding and, if capable of becoming pregnant, I am using effective birth control.I have a history or risk of heart problems.I have been treated with a STING agonist before.I have had pneumonitis treated with steroids or have it now.I have a history of specific lung conditions or currently have lung inflammation.I have not had COVID-19 symptoms or known exposure in the last 14 days.I have not used systemic immunosuppressants in the last 28 days.I do not have an active infection needing treatment, HIV, or hepatitis B/C.My cancer is confirmed to be advanced through testing.I have had fluid build-up causing symptoms that were not controlled in the last 6 months.My heart's electrical activity (QTcF) is within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort
- Group 2: Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort
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.
Are individuals currently being enrolled in this experiment?
"Confirmatively, this research is currently recruiting patients. The posting was first seen on March 12th 2019 and the last update was November 21st 2022."
Answered by AI
Could you summarize any additional investigations that have been conducted surrounding GSK3745417?
"GSK3745417, which was initially examined in 2010 by City of Hope, has already seen 179 trials finished. Currently there are 40 more studies being conducted out of Houston, Texas."
Answered by AI
What is the population volume of this research experiment?
"Affirmative. Information found on clinicaltrials.gov indicates that this medical trial is still recruiting participants; the study was first published in March 12th 2019 and recently amended on November 21st 2022. 300 patients need to be recruited at 3 distinct locations."
Answered by AI
Has the Food and Drug Administration given its seal of approval to GSK3745417?
"As this trial is in its early stages, the safety of GSK3745417 was assigned a score 1. This means that while efficacy has been preliminarily established, there are limited data points verifying safety."
Answered by AI
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