Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
GSK5460025 will be administered
GSK Investigational Site
Chiba, Japan
RECRUITINGGSK Investigational Site
Osaka, Japan
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITINGPart 1: Number of participants with dose limiting toxicities (DLTs) per dose level
Time frame: Up to 28 days
Part 1: Number of participants with treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events (TEAEs) by severity per dose level
Time frame: Up to approximately 33 months
Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period
Time frame: Up to 28 days
Part 1: Number of participants with dosage modifications due to TEAEs per dose level
Time frame: Up to approximately 33 months
Part 2: Objective Response Rate (ORR)
ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.
Time frame: Up to approximately 33 months
Part 1: Plasma concentrations for GSK5460025
Time frame: Up to approximately 36 months
Part 1: Area under the concentration-time curve (AUC) for GSK5460025
Time frame: Up to approximately 36 months
Part 1: Maximum concentration (Cmax) for GSK5460025
Time frame: Up to approximately 36 months
Part 1: Time to maximum concentration (Tmax) for GSK5460025
Time frame: Up to approximately 36 months
Part 1: Number of participants with clinically important changes in laboratory parameters, Electrocardiogram (ECGs), and vital signs per dose level
Time frame: Up to approximately 36 months
Part 2: Number of participants with TESAEs and TEAEs by severity
Time frame: Up to approximately 36 months
Part 2: Number of participants with TEAEs leading to dosage modifications
Time frame: Up to approximately 36 months
Part 2: Number of participants with clinically important changes in laboratory parameters, ECGs, and vital signs
Time frame: Up to approximately 36 months
Part 2: Progression-free Survival (PFS)
PFS is defined as time from first dose to progressive disease (as assessed per RECIST 1.1 by Investigator assessment) or death from any cause, whichever is earlier
Time frame: Up to approximately 36 months
Part 2: Duration of Response (DoR)
DoR is defined as time from first documented PR or CR to progressive disease (as assessed per RECIST 1.1 by investigator assessment) or death from any cause, whichever is earlier for participants who have achieved a confirmed CR or PR.
Time frame: Up to approximately 36 months
Part 2: Plasma concentration of GSK5460025
Time frame: Up to approximately 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.