First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumours

Official Title

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumours

Summary:

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumours or metastatic solid tumours where curative or standard treatment options have been exhausted

Trial Description

Primary Outcome:

  • Number of participants with dose-limiting toxicities (DLTs)
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome:
  • Number of participants with clinically significant changes in laboratory parameters, electrocardiogram (ECG) and vital signs
  • Number of participants with dose reductions or delays
  • Number of participants with withdrawals due to AEs
  • Overall response rate (ORR)
  • Number of participants with positive antidrug antibodies (ADA) to GSK4381562
  • Titers of ADA to GSK4381562
  • Number of participants with positive ADA to dostarlimab
  • Titers of ADA to dostarlimab
  • Plasma concentrations of GSK4381562
  • Maximum observed plasma concentration (Cmax) of GSK4381562 monotherapy
  • Cmax of GSK4381562 in combination with dostarlimab
  • Minimum observed plasma concentration (Cmin) of GSK4381562 monotherapy
  • Cmin of GSK4381562 in combination with dostarlimab
  • Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC[0-t]) of GSK4381562
  • AUC(0-t) of GSK4381562 in combination with dostarlimab
  • AUC from time zero to infinity (AUC[0-infinity]) of single dosing of GSK4381562
  • AUC(0-infinity) of single dosing of GSK4381562 in combination with dostarlimab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society