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.
Treatment: GSK5733584 — The 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.
Check if I qualifyExtracted 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
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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