GSK5471713: GSK5471713 will be administered at different dose levels based on the dose escalation study design
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with dose limiting toxicities (DLTs) — 28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs) — Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity — Approximately 45 months
Number of participants with AEs leading to dose modifications — Approximately 45 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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