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Monoclonal Antibodies

GSK5733584 for Cancer

Phase 1

Waitlist Available

Research Sponsored by GlaxoSmithKline

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

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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 31 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of participants with dose limiting toxicity (DLT)

Part 2: Objective Response Rate (ORR)

Secondary outcome measures

Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584

Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)

Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)

+37 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,772 Previous Clinical Trials

8,106,663 Total Patients Enrolled

~160 spots leftby Oct 2026

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