Actively Recruiting
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
Led by GlaxoSmithKline · Updated on 2026-04-24
85
Participants Needed
15
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent and comply with study requirements
- Male participants aged 18 years or older
- Agree to refrain from donating sperm during the study and for at least 195 days after last dose
- Either abstinent from heterosexual intercourse or agree to use contraception including male condoms
- Histologically or cytologically confirmed prostate adenocarcinoma with metastatic disease
- Castration-resistant status as defined by PCWG3 criteria
- Prior failure of novel anti-androgen therapy and 1-2 taxane-based chemotherapy treatments
- Presence of at least one soft tissue lesion, rising PSA with low testosterone, or bone disease per PCWG3 criteria
- Documented disease progression on most recent systemic therapy
- Serum testosterone level below 50 ng/dL maintained by orchiectomy or continuous androgen-deprivation therapy
- ECOG performance status of 0 or 1 with no recent deterioration
- Provide tumor tissue for PSMA expression and biomarker analysis
- Adequate organ function
You will not qualify if you...
- Small cell or neuroendocrine carcinoma of the prostate or non-adenocarcinoma histology
- History of central nervous system metastases or leptomeningeal disease
- Invasive malignancy other than prostate cancer within last 5 years, with some exceptions
- Ongoing adverse reactions from prior therapy above Grade 1, excluding certain conditions
- Confirmed or recurrent autoimmune disease requiring systemic treatment within 2 years
- Evidence or history of interstitial lung disease or non-infectious pneumonitis requiring steroids
- Any anti-cancer or systemic biologic therapy within 4 weeks prior to study dose
- Prior PSMA radionuclide therapy within 2 months unless fewer than 2 cycles received
- Prior PSMA CAR-T cell therapy or other prostate tumor-associated antigen T cell engagers
- History of bone marrow or solid organ transplant
- Known allergies to study drug components
- Severe neurological or psychiatric disorders interfering with assessments
- Major surgery within 4 weeks before first dose
- Serious infections within 4 weeks before first dose
- Liver function abnormalities exceeding specified limits
- Positive Hepatitis B surface antigen or active Hepatitis C infection
- Inability to comply with study procedures and follow-up requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
GSK Investigational Site
Denver, Colorado, United States, 80218
Actively Recruiting
2
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
4
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
5
GSK Investigational Site
Lyon, France, 69373
Actively Recruiting
6
GSK Investigational Site
Villejuif, France, 94805
Actively Recruiting
7
GSK Investigational Site
Kanagawa, Japan, 232-0024
Actively Recruiting
8
GSK Investigational Site
Tokyo, Japan, 104-0045
Actively Recruiting
9
GSK Investigational Site
Tokyo, Japan, 135-8550
Actively Recruiting
10
GSK Investigational Site
Badajoz, Spain, 06080
Actively Recruiting
11
GSK Investigational Site
Barcelona, Spain, 08023
Actively Recruiting
12
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
13
GSK Investigational Site
Madrid, Spain, 28050
Actively Recruiting
14
GSK Investigational Site
Málaga, Spain, 29010
Actively Recruiting
15
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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