Recruiting

Phase 1

Phase 2

GSK5471713First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

Sponsor:

GlaxoSmithKline

Code:

NCT07332455

Conditions

Neoplasms, Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5471713

Study Details

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.

Conditions

Neoplasms, Prostate

Study ID

NCT07332455

Start date

Feb 10, 2026

Status verified date

Jul, 2026

Completion date

Mar 26, 2030

Anticipated

Primary completion date

Mar 24, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving GSK5471713

Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.

Interventions

GSK5471713

GSK5471713 will be administered at different dose levels based on the dose escalation study design

Primary outcome measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 28 days ]
Number of participants with adverse events (AEs), and serious adverse events (SAEs) [ Time Frame: Approximately 45 months ]
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity [ Time Frame: Approximately 45 months ]
Number of participants with AEs leading to dose modifications [ Time Frame: Approximately 45 months ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

La Jolla, California, United States, 92093

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Rana McKay

GSK Investigational Site

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Emerson Lim

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kevin Zarrabi

GSK Investigational Site

Recruiting

West Valley City, Utah, United States, 84119

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jose Pacheco

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Srikala Sridhar

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramy Saleh

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

Metastatic castration-resistant prostate cancer
First-Time-in-Human
GSK5471713
Prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-24.