NCT07332455RecruitingPhase 1/2
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
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)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- 10 Feb 2026
- Primary completion date
- 24 Mar 2028
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Prostate cancer
- NCT number
- NCT07332455
- EudraCT number
- 2025-523874-17
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 54
- From 10 Feb 2026 to the primary completion date, 24 Mar 2028
- 17 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.
Other illness
- Impaired cardiac function or clinically significant cardiac disease.
Lab values
- Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.
Other
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.