Tests GSK5471713 in adults with advanced prostate cancer
Tests the new drug GSK5471713 alone in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Key facts
- Where
- Montpellier and Villejuif, FranceSee the 2 sites
- Phase
- Phase 1/2
Where in France
- MontpellierMontpellier, FranceTaking people
- VillejuifVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07332455
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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.