Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around
Principal Investigator
by Nicolaos Palaskas

Description

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.

Official Title

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)

Keywords

Neoplasms, Prostate, Metastatic castration-resistant prostate cancer, First-Time-in-Human, GSK5471713, Prostate cancer, Prostatic Neoplasms

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 and life expectancy of ≥3 months (≥12 weeks).
  • 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. Participants should have received all approved standard-of-care therapies for which they are eligible, including biomarker directed therapy, in accordance with current clinical guidelines, unless a documented contraindication or another justified medical reason precluded their use.

You CAN'T join if...

  • Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.
  • Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • GSK Investigational Site accepting new patients
    Los Angeles California 90095 United States
  • GSK Investigational Site accepting new patients
    La Jolla California 92093-1503 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
Links
Sign up for this study
ID
NCT07332455
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 54 study participants
Last Updated