RightFit
RecruitingPhase 1 / Phase 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GSK5471713 alone in humans for the first time. It is for adults with prostate cancer that has spread and keeps growing despite treatment to lower male hormones (mCRPC). Researchers will study its safety, how the body handles it, and early signs that it may help.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a cancer of gland cells, confirmed by a tissue or cell test.
  • Have prostate cancer that has spread and gotten worse while on treatment to lower male hormones (ADT).
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have cancer that got worse after ADT and at least one androgen receptor pathway inhibitor (ARPI), a drug that blocks male hormone signals.
  • Have received 1–2 courses of taxane-based chemotherapy, a type of cancer drug treatment.

Who can't join

  • Have a prostate cancer type other than adenocarcinoma, such as small cell or neuroendocrine cancer.
  • Have poor heart function or serious heart disease.
  • Have another major health problem, such as an infection that is not controlled or a serious abnormal lab result.
  • Have previously received an androgen receptor degrader, a treatment that breaks down a protein that receives male hormone signals.
  • Other study rules may also affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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.

Study sites (4)

CA

MI

PA

UT