This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
GSK5471713 will be administered at different dose levels based on the dose escalation study design
GSK Investigational Site
La Jolla, California, United States
RECRUITINGGSK Investigational Site
Grand Rapids, Michigan, United States
Number of participants with dose limiting toxicities (DLTs)
Time frame: 28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Time frame: Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Time frame: Approximately 45 months
Number of participants with AEs leading to dose modifications
Time frame: Approximately 45 months
Maximum plasma concentration (Cmax) of GSK5471713
Time frame: Approximately 45 months
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
Time frame: Approximately 45 months
Time to maximum plasma concentration (Tmax) of GSK5471713
Time frame: Approximately 45 months
Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate
PSA50 response is defined as a greater than or equal to (\>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later.
Time frame: Approximately 45 months
Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment
ORR is defined as the percentage of participants in the ORR Evaluable set who have the Best overall response (BOR) of confirmed Complete response (CR) or Partial response (PR) per PCWG3 guidelines as assessed by investigator.
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GSK Investigational Site
Philadelphia, Pennsylvania, United States
RECRUITINGGSK Investigational Site
West Valley City, Utah, United States
RECRUITINGGSK Investigational Site
Melbourne, Victoria, Australia
RECRUITINGGSK Investigational Site
Toronto, Ontario, Canada
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGGSK Investigational Site
Montpellier, France
RECRUITINGGSK Investigational Site
Tokyo, Japan
RECRUITING...and 6 more locations
Time frame: Approximately 45 months