First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.