臨床研究等提出・公開システム

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

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Pending

Sept. 17, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

Both

advanced solid tumor

Drug: GSK5733584
GSK5733584 will be administered intravenously.

Part 1: Number of participants with dose limiting toxicity (DLT)
Part 2: Objective Response Rate (ORR)

PK parameter (Cmax, Tmax, AUC), efficacy (ORR, DCR, DoR, PFS, OS), safety (AEs, SAEs), frequency and titers of ADA, etc.

No

United States/Canada/Australia