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

RecruitingPhase 1, Phase 2

Sponsor: GlaxoSmithKline

Conditions: Neoplasms, Prostate

Interventions: GSK5471713

Countries: United States, Australia, Canada, Japan, South Korea

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (11)

La Jolla, California, United States
Grand Rapids, Michigan, United States
Philadelphia, Pennsylvania, United States
West Valley City, Utah, United States
Melbourne, Victoria, Australia
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Tokyo, Japan
Tokyo, Japan
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, South Korea