A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 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 (SYLVER)

Colorectal, Neoplasms

"Part 1: Incidence of participants with DLTs per dose level in the DLT observation periods. ", "Part 1: Incidence of treatment-emergent adverse events (TEAEs) per dose level in the DLT observation periods. ", Part 1: Incidence of dosage interruptions, dose reductions, and drug discontinuations for TEAEs, per dose level in the DLT observation periods., Part 2: Overall response rate, defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment., "Part 3: Incidence of participants with DLTs per dose level in the DLT observation periods. ", "Part 3: Incidence of TEAEs per dose level in the DLT observation periods. ", Part 3: Incidence of dosage interruptions, dose reductions, and drug discontinuations for TEAEs, per dose level in the DLT observation periods.

"Part 1: PK parameters, as available, for GSK4418959 (Key parameters such as AUC, Cmax, Tmax). ", "Part 1: Overall incidence of TEAEs per dose level. ", "Part 1: Overall incidence of dosage interruptions, reductions, and drug discontinuations for TEAEs, per dose level. ", Part 1: Laboratory abnormalities for key parameters as characterized by type, frequency, severity, and timing., "Part 2: Incidence of TEAEs in Part 2. ", "Part 2: Overall incidence of dosage interruptions, dose reductions, and drug discontinuations for TEAEs, per dose level. ", "Part 2: Laboratory abnormalities for key parameters. ", "Part 2: Progression-free survival, defined as time from first dose to progressive disease or death from any cause, whichever is earlier. ", Part 2: Duration of Response, defined as time from first documented PR or CR to progressive disease or death from any cause, whichever is earlier for participants who have achieved a confirmed CR or PR., Part 2: Plasma PK concentrations, as available, for GSK4418959., "Part 3: PK parameters, as available, for GSK4418959 (Key parameters such as AUC, Cmax, Tmax). ", "Part 3: Overall incidence of TEAEs per dose level. ", "Part 3: Overall incidence of dosage interruptions, reductions, and drug discontinuations for TEAEs, per dose level. ", Part 3: Laboratory abnormalities for key parameters as characterized by type, frequency, severity, and timing.

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