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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
Must not have
History of vasculitis at any time prior to study treatment
Current unstable liver or biliary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a new drug, GSK3745417, alone and with another drug, dostarlimab, in patients whose solid tumors have not responded to other treatments or have returned. The goal is to find the best dose and see if these drugs can help shrink the tumors. Dostarlimab is recently approved for the treatment of various cancers, including certain types of endometrial cancer.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had vasculitis in the past.
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My liver condition is stable.
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I have a history of serious bleeding or blood clotting issues.
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I have had issues like severe gut inflammation or blockage in the last 6 months.
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I have fully recovered from any recent surgeries before starting the study treatment.
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I have had a bone marrow or organ transplant.
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I haven't used any cancer drugs or investigational devices in the last 28 days or within 5 half-lives of the drug.
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I have a history or risk of heart problems.
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I have been treated with a STING agonist before.
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I have had pneumonitis treated with steroids or have it now.
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I have a history of specific lung conditions or currently have lung inflammation.
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I do not have an active infection needing treatment, HIV, or hepatitis B/C.
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I have had fluid build-up causing symptoms that were not controlled in the last 6 months.
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My heart's electrical activity (QTcF) is within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial 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 3
~1760
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tumors often involve immune modulation and direct anti-tumor activity. Immune checkpoint inhibitors, such as PD-1/PD-L1 and CTLA-4 inhibitors, enhance the immune system's ability to attack cancer cells by blocking proteins that suppress immune responses.
Targeted therapies, like BRAF inhibitors, focus on specific genetic mutations within cancer cells to inhibit their growth and survival. These mechanisms are important for tumor patients as they provide more personalized and effective treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.
Dual Targeting Autoimmunity and Cancer: From Biology to Medicine.
Dual Targeting Autoimmunity and Cancer: From Biology to Medicine.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,794 Previous Clinical Trials
8,177,564 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,602 Previous Clinical Trials
6,144,787 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors
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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.
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