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 Phoenix, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT06990880
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

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

First listed
May 25, 2025
Start date
Jun 12, 2025
Status verified
Jun 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 (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePhoenixArizona85054
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Yousef Zakharia (PRINCIPAL_INVESTIGATOR)
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 SiteNew HavenConnecticut06510
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Daniel Petrylak (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteRochesterMinnesota55905
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Dan Childs (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteEast BrunswickNew Jersey08816
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Bruno Fang (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)

Find similar trials in Phoenix, AZ

By research site
GSK Investigational Site· Phoenix, AZGSK Investigational Site· Denver, COGSK Investigational Site· New Haven, CTGSK Investigational Site· Rochester, MNGSK Investigational Site· East Brunswick, NJGSK Investigational Site· Nashville, TN

Related Studies