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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participants at least 18 years of age (≥18 years)
Participants with histologically confirmed advanced/metastatic solid tumors, irrespective of mutational status, who have progressed on or are intolerant to all available standard of care therapies or who have progressed on one or more prior lines of therapy
Must not have
Any of the following cardiac examination abnormality: QTc >450 msec or >480 msec for participants with bundle branch block, evidence of current clinically significant arrhythmias or ECG abnormalities, risk factors of prolonged QTc or arrhythmia events, LVEF <50%
Evidence of brain metastasis or untreated progression due to brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 33 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety, effectiveness, and how the body processes GSK5764227 at different doses over time.
Who is the study for?
This trial is for individuals with advanced solid tumors. Specific eligibility criteria are not provided, but typically participants must have measurable disease and adequate organ function, and may need to meet certain lab value thresholds.
What is being tested?
The study is testing GSK5764227's safety, how well it's tolerated by patients, its effectiveness against tumors, and how the body processes it at various doses. Topotecan is also being used; possibly as a comparison or in combination.
What are the potential side effects?
While specific side effects aren't listed here, drugs like GSK5764227 often cause symptoms such as nausea, fatigue, diarrhea or constipation. Side effects can vary widely based on individual patient factors.
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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My advanced cancer has not responded to or I cannot tolerate standard treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart test shows abnormal rhythms or I have a weak heart.
Select...
My cancer has spread to my brain.
Select...
I have been treated with specific medications before.
Select...
I still have side effects from previous treatments that haven't improved.
Select...
I do not have severe heart issues, uncontrolled high blood pressure, serious bleeding, lung disease, or history of certain lung conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 33 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1b: Objective Response Rate (ORR)
Phase 1b: Progression-free survival (PFS)
Secondary study objectives
Phase 1a and Phase 1b: Disease control rate (DCR)
Phase 1a and Phase 1b: Duration of Response (DoR)
Phase 1a: Objective Response Rate
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1b: Dose expansion-GSK5764227Experimental Treatment1 Intervention
Group II: Phase 1a: Dose escalation-GSK5764227Experimental Treatment1 Intervention
Group III: Phase 1b: Dose expansion- TopotecanActive Control1 Intervention
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,806 Previous Clinical Trials
8,380,589 Total Patients Enrolled
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