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)

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 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.