A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
GlaxoSmithKline
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Progression on ADT and \>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens. Exclusion Criteria: * Pathological finding consisten…
Interventions
- DrugGSK5471713
GSK5471713 will be administered at different dose levels based on the dose escalation study design
Locations (6)
- GSK Investigational SiteGrand Rapids, Michigan
- GSK Investigational SitePhiladelphia, Pennsylvania
- GSK Investigational SiteWest Valley City, Utah
- GSK Investigational SiteToronto, Ontario
- GSK Investigational SiteMontreal, Quebec
- GSK Investigational SiteTokyo