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

NCT ID: NCT07332455

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-27

Study Completion Date

2030-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms, Prostate

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants receiving GSK5471713

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

Group Type EXPERIMENTAL

GSK5471713

Intervention Type DRUG

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

Interventions

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GSK5471713

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Central Contacts

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US GSK Clinical Trials Call Center

Role: CONTACT

877-379-3718

EU GSK Clinical Trials Call Center

Role: CONTACT

+44 (0) 20 89904466

Other Identifiers

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2025-523874-17

Identifier Type: OTHER

Identifier Source: secondary_id

300164

Identifier Type: -

Identifier Source: org_study_id

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