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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care)
Be older than 18 years old
Must not have
Has inadequate bone marrow reserve or hepatic/renal functions
Have received any of B7-H4-targeted therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 31 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to check if GSK5733584 is safe and well-tolerated. It will also examine how the levels of GSK5733584 change over time with different doses.
Who is the study for?
Adults with advanced solid tumors who've failed or can't tolerate standard treatments, have a life expectancy of at least 12 weeks, and are generally in stable condition (ECOG PS score of 0-2). They must have measurable cancer and provide tissue samples for biomarker analysis. Excluded are those with poor marrow or organ function, heart issues, certain ECG abnormalities, recent major surgeries or therapies.
What is being tested?
The trial is testing GSK5733584's safety and how the body processes it at different doses in people with advanced solid tumors. It will involve regular monitoring to determine the appropriate dosage levels and observe any clinical response to the treatment.
What are the potential side effects?
While specific side effects aren't listed here, common ones for similar drugs include reactions at injection site, fatigue, nausea, changes in blood counts affecting immunity/clotting/oxygenation; liver/kidney function alterations; potential heart rhythm changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has not responded to standard treatments.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My bone marrow, liver, or kidney functions are not normal.
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I have received treatments targeting B7-H4.
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I have or had lung inflammation that needed strong steroids.
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I have brain metastasis but no symptoms.
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I have not had major surgery in the last 4 weeks.
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I haven't had major radiation therapy in the last 4 weeks.
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I need treatment for fluid buildup in my chest or abdomen.
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I do not have severe heart problems, uncontrolled high blood pressure, serious bleeding, or blood clot issues.
Select...
I haven't taken any cancer drugs or traditional Chinese medicines in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 31 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 2: Objective Response Rate (ORR)
Secondary study objectives
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,381,078 Total Patients Enrolled
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