A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
GlaxoSmithKline
Study ID
NCT06990880
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neoplasms, Prostate

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK5458514 — DRUG
    GSK5458514 will be administered.

Study Details

The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).

Key Dates

Start date
Jun 12, 2025
Status verified
Apr 2026
Primary completion
Oct 26, 2027
Completion
Aug 9, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose escalation of GSK5458514 monotherapy
  • Experimental: Part 2: Dose expansion of GSK5458514 monotherapy

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) during DLT observation period [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDenverColorado80218
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Gerald Falchook (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNashvilleTennessee37203
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Benjamin Garmezy (PRINCIPAL_INVESTIGATOR)

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By research site
GSK Investigational Site· Denver, COGSK Investigational Site· Nashville, TN

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