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

Description

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.

Conditions

Solid Tumors, Neoplasms

Study Overview

Study Details

Study overview

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.

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

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Lake Mary

GSK Investigational Site, Lake Mary, Florida, United States, 32746

Boston

GSK Investigational Site, Boston, Massachusetts, United States, 02114

Boston

GSK Investigational Site, Boston, Massachusetts, United States, 02215

Detroit

GSK Investigational Site, Detroit, Michigan, United States, 48201

Dallas

GSK Investigational Site, Dallas, Texas, United States, 75230

West Valley City

GSK Investigational Site, West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * Participants have at least one target lesion as assessed per the RECIST 1.1
  • * Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
  • * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
  • * Have a life expectancy of at least 12 weeks.
  • * 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 4 weeks 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,
  • * 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
  • * Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2027-01-21