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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
GSK5533524 will be administered.
GSK Investigational Site
Philadelphia, Pennsylvania, United States
RECRUITINGGSK Investigational Site
San Antonio, Texas, United States
RECRUITINGGSK Investigational Site
Toronto, Ontario, Canada
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGGSK Investigational Site
Helsinki, Finland
RECRUITINGGSK Investigational Site
Saitama, Japan
RECRUITINGGSK Investigational Site
Shizuoka, Japan
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITING...and 6 more locations
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Time frame: Up to 21 days
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Time frame: Up to approximately 34 months
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).
Time frame: Up to approximately 27 months
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
Time frame: Up to approximately 34 months
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.
Time frame: Up to approximately 27 months
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.
Time frame: Up to approximately 27 months
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
Time frame: Up to approximately 27 months
Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524
Time frame: Up to approximately 27 months
Part 1a & 1b: Titers of ADA against GSK5533524
Time frame: Up to approximately 27 months
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