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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Primary Objective:

To evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors to establish MTD or maximum applicable dose (MAD).

Secondary objectives:

To evaluate the PK profile of GSK5733584 administered intravenously in subjects with advanced solid tumors.
To evaluate the clinical activity of GSK5733584 administered intravenously in subjects with advanced solid tumors.
To evaluate the immunogenicity of GSK5733584 administered intravenously in subjects with advanced solid tumors.
To further evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors

Eligibility

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).
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.

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 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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices