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OncoMatch/Clinical Trials/NCT06431594

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors

Is NCT06431594 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GSK5733584 for solid tumors.

Phase 1RecruitingGlaxoSmithKlineNCT06431594Data as of May 2026

Treatment: GSK5733584The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: VTCN1 expression by IHC (testing required; no eligibility threshold specified) (testing required; no eligibility threshold specified)

Tumor tissue ... is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis.

Allowed: FOLR1 overexpression

Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtasine if the participants was considered a candidate for this regimen and the regimen is locally available.

Allowed: BRCA1 mutation

Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.

Allowed: BRCA2 mutation

Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: platinum-based chemotherapy — endometrial cancer cohort

Must have had prior platinum ... if considered a candidate for this regimen and the regimen is locally available.

Must have received: anti-PD-1 therapy — endometrial cancer cohort

Must have had prior ... PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.

Must have received: bevacizumab (bevacizumab) — PROC cohort

Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.

Cannot have received: B7-H4-targeted therapy

Have received any of B7-H4-targeted therapies.

Cannot have received: cytotoxic chemotherapy

Exception: within 28 days prior to the first dose of study drug

Have received any of cytotoxic chemotherapy drugs ... within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.

Cannot have received: topoisomerase inhibitor

Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)

Cannot have received: antibody-drug conjugate

Have received prior therapy with ... topoisomerase inhibitor Antibody-drug conjugate (ADCs)

Lab requirements

Blood counts

Has inadequate bone marrow reserve [excluded]

Kidney function

Has inadequate renal function [excluded]

Liver function

Has inadequate hepatic function [excluded]

Cardiac function

Mean Fridericia-corrected QT interval (QTcF) > 470 msec on resting ECG; Evidence of current clinically significant arrhythmias or ECG abnormalities; Risk factors of prolonged QTc or arrhythmia events; Left ventricular ejection fraction (LVEF) < 50%; Severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events [excluded]

Has inadequate bone marrow reserve or hepatic/renal functions. Mean Fridericia-corrected QT interval (QTcF) > 470 msec on resting ECG. Evidence of current clinically significant arrhythmias or ECG abnormalities. Risk factors of prolonged QTc or arrhythmia events. Left ventricular ejection fraction (LVEF) < 50%. Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • GSK Investigational Site · Lake Mary, Florida
  • GSK Investigational Site · Fairway, Kansas
  • GSK Investigational Site · Boston, Massachusetts
  • GSK Investigational Site · Boston, Massachusetts
  • GSK Investigational Site · Detroit, Michigan

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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