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

RECRUITINGPHASE1

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

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

NCT06431594•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females aged 18 years or older (≥18 years).
•Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
•PROC cohort
•1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
•2. Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
•3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
•4. Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.
•5. 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.
•6. 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.
•Endometrial cancer cohort
+8 more criteria

Exclusion Criteria

•Have received any of B7-H4-targeted therapies.
•Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
•Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
•Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
•Major surgery within 28 days prior to the first dose of study treatment.
•Evidence of brain metastasis unless asymptomatic.
•Has inadequate bone marrow reserve or hepatic/renal functions.
•Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG.
•Evidence of current clinically significant arrhythmias or ECG abnormalities
•Risk factors of prolonged QTc or arrhythmia events,
+8 more criteria

Locations (47)

GSK Investigational Site

Lake Mary, Florida, United States

GSK Investigational Site

Fairway, Kansas, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Grand Rapids, Michigan, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

West Valley City, Utah, United States

GSK Investigational Site

Cipoletti Rio Negro, Argentina

Key Dates

Start Date

July 2, 2024

Primary Completion Date

February 1, 2027

Completion Date

September 20, 2027

Last Updated

June 25, 2025

Enrollment

385

ESTIMATED participants

Conditions

Solid TumorsNeoplasms

Interventions

GSK5733584

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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