The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how well people tolerate it, so researchers can choose the best dose for the next stage of testing. The study will also check whether the drug can shrink tumours or slow cancer growth, monitor how the body absorbs and breaks down the drug, and look for any immune reactions that the body might develop against the treatment.
Is at least 18 years of age or the legal age of consent
Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory or intolerant to standard therapy, has exhausted all treatment options and is not considered a candidate for definitive radiotherapy.
Has documented disease progression based on radiologic imaging, during or after most recent line of treatment.
Has at least one target lesion per RECIST 1.1.
Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy.
Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion.
Has untreated brain or central nervous system metastases or metastases that have progressed
Has a Grade ≥2 corneal epithelial condition.
Sequential
GSK5533524
DrugGSK5533524 will be administered.
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Part 1b: Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Part 1a & 1b: Number of participants with adverse events (AEs), serious adverse events (SAEs), Treatment-Emergent AEs (TEAEs) by severity, Adverse Events of Special Interest (AESIs), and AEs leading to dose modifications and treatment discontinuation
Part 1a: Objective Response Rate (ORR)
ORR is the proportion of participants with a BOR of CR or PR as assessed by the investigator according to RECIST 1.1.
Part 1a & 1b: Duration of Response (DoR)
DoR is evaluated in participants who achieve a CR or PR, based on investigator assessment per RECIST 1.1.
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
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