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Taking people in United StatesPhase 1/2

Tests GSK5471713 in adults with advanced prostate cancer

Tests the new drug GSK5471713 alone in adults with advanced prostate cancer.

Key facts

Who runs it
GlaxoSmithKline
Where
Grand Rapids, La Jolla, Los Angeles, Philadelphia, and West Valley City, United StatesSee the 5 sitesAlso in 7 other countries, 12 sites
Registry title
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Status
Recruiting
Phase
Phase 1/2
People taking part
54 people, planned
Started
10 Feb 2026
Expected to end
26 Mar 2030
Type of study
Interventional
Treatments tested
  • GSK5471713
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They must have already had several standard treatments.

Age
18 years or older
Sex
Men only
Disease stage
Prostate cancer that has spread (metastatic) and keeps growing despite hormone-lowering treatment (androgen deprivation therapy). The cancer cells must be of the adenocarcinoma type.
Earlier treatment
Must have had hormone-lowering treatment (ADT), at least 1 androgen receptor pathway inhibitor, and 1-2 earlier taxane-based chemotherapy regimens. Must also have had the approved standard treatments they could receive, unless a documented medical reason ruled them out.

Main reasons for not taking part

  • Small cell or neuroendocrine prostate cancer, or any cancer type other than adenocarcinoma
  • Weak heart function or serious heart disease
  • Other serious medical problems, such as an infection that is not under control
  • Earlier treatment with an androgen receptor (AR) degrader

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

Also in 7 other countries, 12 sites

  • Grand Rapids, MichiganHospital not named in the registryContact: Emerson Lim (principal investigator)Taking people
  • La Jolla, CaliforniaHospital not named in the registryContact: Rana McKay (principal investigator)Taking people
  • Los Angeles, CaliforniaHospital not named in the registryContact: Nicolaos Palaskas (principal investigator)Taking people
  • Philadelphia, PennsylvaniaHospital not named in the registryContact: Kevin Zarrabi (principal investigator)Taking people
  • West Valley City, UtahHospital not named in the registryContact: Jose Pacheco (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Participants receiving GSK5471713Treatment being tested

    Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.

    Treatment: GSK5471713

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests GSK5471713 in adults with advanced prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
9 November 2026