A Phase 1/2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors
Summary
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.
Arms & interventions
- DrugGSK5460025
GSK5460025 will be administered
Outcome measures
Primary
Part 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
Secondary
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)
Time frame: Up to approximately 36 months
Part 2: Duration of Response (DoR)
Time frame: Up to approximately 36 months
Part 2: Plasma concentration of GSK5460025
Time frame: Up to approximately 36 months
Eligibility criteria
Study locations (4)
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Nashville, Tennessee, 37203