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 GSK4418959 alone or in combination with a PD-1 inhibitor agent can decrease tumor size, is safe, well-tolerated, and how amounts of the study drug decrease in the body over time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
GSK4418959 will be administered.
PD-1 inhibitor will be administered.
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Leuven, Belgium
...and 12 more locations
Part 1: Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Time frame: Up to 21 days
Part 3: Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Time frame: Up to 21 days
Part 1: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period
Time frame: Up to 21 days
Part 3: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period
Time frame: Up to 21 days
Part 1: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period
Time frame: Up to 21 days
Part 3: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period
Time frame: Up to 21 days
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 26 months
Part 1: Area under the concentration-time curve (AUC) for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 1: Maximum concentration (Cmax) for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 1: Time to maximum concentration (Tmax) for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 3: AUC for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 3: Cmax for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 3: Tmax for GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 1: Number of participants with TEAEs
Time frame: Up to approximately 42 months
Part 2: Number of participants with TEAEs
Time frame: Up to approximately 42 months
Part 3: Number of participants with TEAEs
Time frame: Up to approximately 42 months
Part 1: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs
Time frame: Up to approximately 42 months
Part 2: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs
Time frame: Up to approximately 42 months
Part 3: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs
Time frame: Up to approximately 42 months
Part 1: Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 42 months
Part 2: Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 42 months
Part 3: Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 42 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 42 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 42 months
Part 2: Plasma concentration of GSK4418959
Time frame: From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
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